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    Summary
    EudraCT Number:2010-018386-32
    Sponsor's Protocol Code Number:CC-10004-PSA-003
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2010-11-30
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - BfArM
    A.2EudraCT number2010-018386-32
    A.3Full title of the trial
    A Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study of two doses of Apremilast (CC-10004) in subjects with active psoriatic arthritis
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 study to evaluate safety and effectiveness of oral Apremilast
    (CC-10004) in patients with Psoriatic Arthritis
    A.4.1Sponsor's protocol code numberCC-10004-PSA-003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCelgene Corporation
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCelgene Corporation
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCelgene Corporation
    B.5.2Functional name of contact pointClinical Trial Disclosure
    B.5.3 Address:
    B.5.3.1Street Address9900 W. 109th street, suite 300, building 70
    B.5.3.2Town/ cityOverland Park, Kansas
    B.5.3.3Post code66210
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18882601599
    B.5.5Fax number+19134513459
    B.5.6E-mailClinicalTrialDisclosure@celgene.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApremilast
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApremilast
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameApremilast
    D.3.2Product code CC-10004
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNApremilast
    D.3.9.1CAS number 608141-41-9
    D.3.9.2Current sponsor codeCC-10004
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 3
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriatic arthritis, an inflammatory arthritis that occurs in 6 to 39% of patients with psoriasis.
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to evaluate the clinical efficacy of 2 doses of apremilast (20 mg or 30 mg orally BID) compared with placebo, on the signs and symptoms of psoriatic arthritis (PsA) after 16 weeks' administration
    E.2.2Secondary objectives of the trial
    To evaluate the following in subjects with active PsA who are treated with 2 doses of apremilast of placebo for up to 24 weeks:
    - safety and tolerability
    - efficacy
    - physical function
    - fatigue
    - clinical disease activity

    To evaluate the following in subjects with active PsA who are treated with 2 doses of apremilast of placebo for up to 52 weeks:
    - safety and tolerability
    - efficacy
    - physical function
    - fatigue
    - clinical disease activity

    To evaluate the efficacy, safety, and tolerability of 2 doses of apremilast during up to 5 years' administration to subjects with active PsA
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female, aged ≥ 18 years at time of consent.

    2. Must understand and voluntarily sign an informed consent document prior to any study related assessments/procedures being conducted.

    3. Able to adhere to the study visit schedule and other protocol requirements.

    4. Have a documented diagnosis of PsA (by any criteria) of ≥ 6 months’ duration.

    5. Meet the CASPAR criteria for PsA at time of screening.

    6. Have ≥ 3 swollen AND ≥ 3 tender joints, despite prior or current treatment with DMARDs (inadequate control by DMARDs applies to therapeutic failure, loss of insurance, intolerance, adverse effects, or other reasons for discontinuation).

    7. Be receiving treatment on an outpatient basis.

    8. If taking methotrexate, leflunomide, or sulfasalazine, must have been treated for at least 16 weeks and on a stable dose (oral or parenteral methotrexate ≤ 25 mg/week; leflunomide ≤ 20 mg/day; sulfasalazine ≤ 2 g/day) for at least 4 weeks prior to screening and through Week 24 of the study. One reduction in DMARD dose will be permitted after Week 24.

    9. If taking oral corticosteroids, must be on a stable dose of prednisone ≤ 10 mg/day or equivalent for at least 1 month prior to screening.
    10. If taking NSAIDs or narcotic analgesics, must be on stable dose for at least 2 weeks prior to screening and until they have completed the Week 24 study visit.

    11. Low potency topical corticosteroids (Appendix M or locally-available equivalent) will be allowed as background therapy for treatment of psoriasis on the face, axillae and groin in accordance with the manufacturers’ suggested usage during the course of the study. Subjects with scalp psoriasis will be permitted to use coal tar shampoo and/or salicylic acid scalp preparations on scalp lesions. A non-medicated skin emollient (eg, Eucerin cream) will also be permitted for body lesions only. Subjects must not use these treatments within 24 hours prior to the clinic visit.

    12. Meet the following laboratory criteria:
    - White blood cell count  3000/mm3 (≥ 3.0 x 109/L) and < 14,000/mm3
    (< 14 x 109/L)
    - Platelet count ≥ 100,000/mm3 (≥ 100 x 109/L)
    - Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
    - AST (SGOT) and ALT (SGPT) ≤ 2 X upper limit of normal (ULN)
    - Total bilirubin ≤ 2 mg/dL (≤ 34 μmol/L)
    - Hemoglobin ≥ 9 g/dL (≥ 5.6 mmol/L)
    - Hemoglobin A1c ≤ 9.0%

    13. Male subjects (including those who have had a vasectomy) who engage in activity in which conception is possible must use barrier contraception (male latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) while on IP and for at least 28 days after the last dose of IP.

    14. Females of childbearing potential (FCBP) must have a negative pregnancy test at Screening and Baseline. FCBP who engage in activity in which conception is possible must use contraception† while on IP and for at least 28 days after taking the last dose of IP with either: 1) one highly effective form (non-oral hormonal, intrauterine device [IUD], tubal ligation, vasectomized partner); or 2) an oral hormonal contraceptive PLUS one additional form of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane], diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge with spermicide); or 3) two forms of barrier contraception (male or female latex condom or nonlatex condom NOT made out of natural [animal] membrane [for example, polyurethane]) PLUS one of the following (diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge with spermicide).

    Note: The protocol language regarding contraception has been revised. As this study is fully enrolled, the updated language regarding contraception is included in Section 6.2 (Contraception Education) of this amendment.

    † The female subject's chosen form of contraception must be effective by the time the female subject is randomized into the study (for example, hormonal contraception should be initiated at least 28 days before randomization).
    E.4Principal exclusion criteria
    1. History of clinically significant (as determined by the Investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major uncontrolled disease.

    2. Any condition, including the presence of laboratory abnormalities that places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study.

    3. Clinically significant abnormality on 12-lead ECG at Screening.

    4. Pregnant or breast feeding.

    5. History of allergy to any component of the investigational product (IP).

    6. Hepatitis B surface antigen positive at screening.

    7. Hepatitis C antibody positive at screening.

    8. AST (SGOT) and/or ALT (SGPT) > 1.5X ULN and total bilirubin > ULN or albumin
    < LLN.

    9. History of positive Human Immunodeficiency Virus (HIV), or congenital or acquired immunodeficiency (eg, Common Variable Immunodeficiency Disease).

    10. Active tuberculosis or a history of incompletely treated tuberculosis.

    11. Clinically significant abnormality based upon chest radiograph with at least PA view (radiograph must be taken within 12 weeks prior to Screening or during the Screening visit). An additional lateral view is strongly recommended but not required.

    12. Active substance abuse or a history of substance abuse within 6 months prior to Screening.

    13. Bacterial infections requiring treatment with oral or injectable antibiotics, or significant viral or fungal infections, within 4 weeks of Screening. Any treatment for such infections must have been completed at least 4 weeks prior to Screening.

    14. Malignancy or history of malignancy (except for treated [ie, cured] basal-cell or squamous cell in situ skin carcinomas and treated [ie, cured] cervical intraepithelial neoplasia [CIN] or carcinoma in situ of the cervix.

    15. Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following randomization.

    16. Erythrodermic, guttate, or generalized pustular psoriasis at randomization.

    17. Topical therapy for psoriasis, except as noted in the Inclusion Criteria, within 2 weeks of randomization (including but not limited to topical corticosteroids, topical retinoids or vitamin D analog preparations, tacrolimus, pimecrolimus, or anthralin).

    18. Rheumatic autoimmune disease other than PsA, including systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, polymyositis or fibromyalgia.

    19. Functional Class IV as defined by the ACR Classification of Functional Status in Rheumatoid Arthritis (Appendix Q).

    20. Prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, RA, ankylosing spondylitis, Lyme disease).

    21. Use of the following systemic therapy(ies) within 4 weeks of randomization, including but not limited to cyclosporine or other calcineurin inhibitors, corticosteroids and small molecule DMARDs (except as noted in inclusion criteria), oral retinoids, mycophenolate, thioguanine, hydroxyurea, sirolimus, tacrolimus, azathioprine, fumaric acid esters.

    22. Use of phototherapy within 4 weeks of randomization (ie, UVB, PUVA).

    23. Use of adalimumab, etanercept, golimumab, infliximab, certolizumab pegol, or tocilizumab within 12 weeks of randomization.

    24. Use of alefacept or ustekinumab within 24 weeks of randomization.

    25. Previous treatment with any cell depleting therapies, including investigational agents (eg, rituximab, CAMPATH, anti-CD4, anti-CD5, anti-CD3, anti-CD19, and anti-CD20).

    26. Treatment with intravenous gamma globulin, plasmapheresis, or Prosorba® column within 6 months of baseline.

    27. Any previous treatment with alkylating agents such as cyclophosphamide or chlorambucil, or with total lymphoid irradiation.

    28. Prior treatment with apremilast.

    29. Therapeutic failure of > 3 agents for PsA (small molecules or biologics), or > 1 biologic TNF blocker. Subjects who terminated previous treatment with small molecules or biologics due to cost or safety, such as discomfort with the subcutaneous injections, may participate in this study after adequate washout.

    30. Use of any investigational drug within 4 weeks of randomization, or 5 pharmacokinetic/ pharmacodynamic half lives, if known (whichever is longer).
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects in each treatment group who achieve the American College of Rheumatology criteria for a 20% improvement (ACR 20), compared with baseline.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 16 weeks’ treatment
    E.5.2Secondary end point(s)
    • Safety of up to 5 years’ administration as defined by
    - Type, frequency, severity, and relationship of adverse events to apremilast
    - Number of subjects who prematurely discontinue study medication due to any adverse event
    - Frequency of clinically significant changes in physical examination, vital signs,
    electrocardiogram, and/or laboratory findings

    Efficacy at Week 16 (after 16 weeks of treatment):
    - Change from baseline in physical function (Health Assessment
    Questionnaire-Disability Index [HAQ-DI])
    - Change from baseline in the physical function domain score of the Medical Outcome Study Short Form 36-Item Health Survey, Version 2 (SF-36)
    - Proportion of subjects who achieve the modified Psoriatic Arthritis
    Response Criteria (PsARC)
    - Change from baseline in subject's assessment of pain (VAS)
    - Change from baseline in the Maastricht Ankylosing Spondylitis
    Entheses Score (MASES) in subjects with pre-existing enthesopathy
    - Change from baseline in the dactylitis severity score in subjects with pre-existing dactylitis
    - Change from baseline in the Clinical Disease Activity Index (CDAI)
    - Change from baseline in the Disease Activity Score (DAS28)
    - Change from baseline in the Functional Assessment of Chronic Illness
    Therapy –Fatigue (FACIT-Fatigue) score
    - Proportion of subjects with pre-existing enthesopathy whose MASES
    improves by ≥ 20%
    - Proportion of subjects with pre-existing dactylitis whose dactylitis severity score improves by ≥ 1
    - Proportion of subjects with a good or moderate European League
    Against Rheumatism (EULAR) response
    - Proportion of subjects who achieve an ACR 50, compared with baseline
    - Proportion of subjects who achieve an ACR 70, compared with baseline
    - Proportion of subjects with pre-existing enthesopathy whose MASES
    improves to 0
    - Proportion of subjects with pre-existing dactylitis whose dactylitis severity score improves to 0

    Efficacy at Week 24 (after 24 weeks of treatment):
    - Proportion of subjects who achieve the ACR 20, compared with baseline
    - Change from baseline in physical function (HAQ-DI)
    - Change from baseline in the physical function domain score of the SF-
    36
    - Proportion of subjects who achieve the modified PsARC
    - Change from baseline in subject's assessment of pain (VAS)
    - Change from baseline in the MASES in subjects with pre-existing enthesopathy
    - Change from baseline in the dactylitis severity score in subjects with pre-existing dactylitis
    - Change from baseline in the CDAI
    - Change from baseline in the DAS28
    - Change from baseline in the FACIT-Fatigue score
    - Proportion of subjects with pre-existing enthesopathy whose MASES
    improves by ≥ 20%
    - Proportion of subjects with pre-existing dactylitis whose dactylitis severity score improves by ≥ 1
    - Proportion of subjects with a good or moderate EULAR response
    - Proportion of subjects who achieve an ACR 50, compared with baseline
    - Proportion of subjects who achieve an ACR 70, compared with baseline
    - Proportion of subjects with pre-existing enthesopathy whose MASES
    improves to 0
    - Proportion of subjects with pre-existing dactylitis whose dactylitis severity score improves to 0

    Efficacy at Week 52 (after 52 weeks of treatment):
    - Proportion of subjects who achieve the ACR 20, compared with baseline
    - Change from baseline in physical function (HAQ-DI)
    - Change from baseline in the physical function domain score of the SF-
    36
    - Proportion of subjects who achieve the modified PsARC
    - Change from baseline in subject's assessment of pain (VAS)
    - Change from baseline in the MASES in subjects with pre-existing enthesopathy
    - Change from baseline in the dactylitis severity score subjects with pre- existing dactylitis
    - Change from baseline in the CDAI
    - Change from baseline in the DAS28
    - Change from baseline in the FACIT-Fatigue score
    - Proportion of subjects with pre-existing enthesopathy whose MASES
    improves by ≥ 20%
    - Proportion of subjects with pre-existing dactylitis whose dactylitis severity score improves by ≥ 1
    - Proportion of subjects with a good or moderate EULAR response
    - Proportion of subjects who achieve an ACR 50, compared with baseline
    - Proportion of subjects who achieve an ACR 70, compared with baseline
    - Proportion of subjects with pre-existing enthesopathy whose MASES
    improves to 0
    - Proportion of subjects with pre-existing dactylitis whose dactylitis severity score improves to 0
    E.5.2.1Timepoint(s) of evaluation of this end point
    See above
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA52
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Bulgaria
    Canada
    Czech Republic
    Estonia
    France
    Germany
    Hungary
    Italy
    Poland
    Russian Federation
    South Africa
    Spain
    Taiwan
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    See protocol
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 445
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 464
    F.4.2.2In the whole clinical trial 495
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    See protocol
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2010-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-01-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-01-25
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