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    Summary
    EudraCT Number:2008-008337-11
    Sponsor's Protocol Code Number:A3921046
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2009-03-23
    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 ConcernedSweden - MPA
    A.2EudraCT number2008-008337-11
    A.3Full title of the trial
    PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF 2 DOSES OF CP-690,550 IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON BACKGROUND DMARDS
    A.4.1Sponsor's protocol code numberA3921046
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc.
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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.3.2Product code CP-690,550
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To compare the efficacy of CP-690,550 in doses of 5 mg BID and 10 mg BID versus
    placebo for the treatment of signs and symptoms of RA in patients with active RA
    who have had an inadequate response to a DMARD (traditional or biologic), as
    measured by ACR20 response rates at Month 6.
    2. To compare physical function status of patients after administration of CP-690,550 in
    doses of 5 mg BID or 10 mg BID versus placebo using the HAQ-DI at Month 3
    compared to baseline in patients with active RA on background traditional DMARDs.
    3. To compare the rate of achieving DAS 28-4(ESR) <2.6 at Month 6 in patients with
    active RA after administration of CP-690,550, in doses of 5 mg BID and 10 mg BID
    versus placebo.
    4. To evaluate the safety and tolerability of CP-690,550 in doses of 5 mg BID and
    10 mg BID versus placebo in patients with active RA on background traditional
    DMARDs.
    E.2.2Secondary objectives of the trial
    1. To compare the efficacy of CP-690,550 in doses of 5 mg BID and 10 mg BID versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) in patients with active RA on background traditional DMARDs, as measured by ACR20 response rates at Months 1 and 3 and ACR50, ACR70 and DAS 28 response rates at Months 1, 3, and 6.
    2. To compare the durability of ACR20, ACR50, and ACR70 and DAS 28 response rates.
    3. To compare the incidence of DAS 28 remission and low disease activity state at each visit.
    4. To compare effects on all health outcomes measures in the study at each visit, as appropriate for the specific outcome, compared to baseline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1.Rheumatoid arthritis with evidence of disease activity by joint counts and laboratory markers of inflammation.
    2.Ongoing treatment with a traditional background DMARD.
    3.Meet all other eligibility criteria.

    1.Rheumatoid Arthritis Disease Activity:
    To be eligible for participation in this trial, a patient must meet the following criteria:
    1.The patient must meet the American College of Rheumatology classification criteria for the diagnosis of rheumatoid arthritis.
    2.The patient must have active disease at both screening and baseline, as defined by having both:
    a.≥4 tender/painful joints on motion (out of 68 joints assessed); and
    b.≥4 swollen joints (out of 66 joints assessed).
    3.The patient must also have active disease as defined fulfilling 1 of the 2 following criteria at screening only:
    a.Erythrocyte sedimentation rate >28 mm/hr; or
    b.C reactive protein >7 mg/L.
    4.The patient must meet Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.

    2.Background DMARD:
    To be eligible for participation in this trial, a patient must meet the following criteria: 1.Patient must have had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
    2.Patient must remain on at least one background traditional DMARD and be dosed in accordance with the local regulatory label and be willing to remain on that traditional DMARD throughout the course of the study. Combination therapy will be allowed as consistent with local standards.
    a.Methotrexate: Maximum dose of 25 mg/week. Minimum duration of therapy 4 months and dose stable for 6 weeks prior to first dose of study drug. Patients on methotrexate should be on an adequate and stable dose of folic acid (not less than 5 mg weekly, unless higher doses would violate the local label) for at least 4 weeks prior to the first dose of study drug.
    b.Sulfasalazine: Maximum dose of 3 gm/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to first dose of study drug.
    c.Leflunomide: Maximum dose of 20 mg/day. Minimum duration of therapy 4 months and dose stable for 4 weeks prior to first dose of study drug.
    d.Hydroxychloroquine sulfate: Maximum dose of 400 mg/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to first dose of study drug.
    e.Injectable Gold: Maximum dose of 50 mg/week. Minimum duration of therapy 6 months and dose stable for 3 months prior to first dose of study drug.
    f.Penicillamine: Maximum dose of 1000 mg/day. Minimum duration of therapy 6 months and dose stable for 3 months prior to first dose of study drug.
    g.Other traditional DMARDs may be considered after discussion with the Sponsor.

    3.Other Inclusion Criteria:
    Patients must meet all of the following inclusion criteria:
    1.Evidence of a signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    2.Patient must be at least 18 years of age or older.
    3.Patient has discontinued all disallowed concomitant medications for the required time prior to the first dose of study drug and is taking only those concomitant medications in doses and frequency allowed by the protocol.
    4.Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
    5.Sexually active women of childbearing potential and men whose partners are women of childbearing potential are required to use adequate contraceptive methods during participation in this trial.
    6.No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
    •A negative QuantiFERON Gold®™ test or, if unavailable, a Mantoux Purified Protein Derivative skin test.
    •A chest radiograph taken within the 3 months prior to screening without changes suggestive of active TB infection.
    •No history of either untreated or inadequately treated latent or active TB infection.
    A patient who is currently being treated for either latent or active TB infection can only be enrolled with confirmation of current incidence rates of multi drug resistant TB infection, documentation of an adequate treatment regimen, and with prior approval by the Sponsor.
    7.Patients receiving non prohibited concomitant medications for any reason must be on a stable regimen, which is defined as not starting a new drug or changing dosage within 7 days or 5 half lives (whichever is longer) prior to first study dose.

    Please refer to the protocol for a complete list of the inclusion criteria.
    E.4Principal exclusion criteria
    Patients presenting with any of the following will not be included in the study:
    1. Any DMARD use that would be contraindicated according to the local prescribing information, including use as a background medication.
    2. Pregnant or lactating females.
    3. Blood dyscrasias including confirmed:
    • Hemoglobin <9 g/dL or Hematocrit <30%;
    • White blood cell count <3.0 x 10 to the power 9/L;
    • Absolute neutrophil count <1.2 x 10 to the power 9/L;
    • Platelet count <100 x 10 to the power 9/L.
    4. Estimated GFR <40 ml/min based on Cockcroft-Gault calculation.
    5. AST or ALT greater than 1.5 times the upper limit of normal at screening or any uncontrolled clinically significant laboratory abnormality that would affect interpretation of study data or the patient’s participation in the study.
    6. Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, or neurological disease.
    7. History of any other rheumatic autoimmune disease other than Sjogren’s syndrome.
    8. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
    9. History of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
    10. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    11. History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug.
    12. History of any infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug.
    13. Any prior treatment with non B cell-specific lymphocyte depleting agents/therapies [eg, alemtuzumab (Campath®), alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc]. Patients who have received rituximab or other selective B lymphocyte depleting agents (including experimental agents) are eligible if they have not received such therapy for at least 1 year prior to study baseline and have normal CD 19/20+ counts by FACS analysis.
    14. Any patient who has been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study drug or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study drug.
    15. A patient with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding, that simply divide the stomach into separate chambers, are NOT exclusionary.
    16. History of alcohol or drug abuse with less than 6 months of abstinence prior to first dose of study drug.
    17. Screening 12-lead ECG that demonstrates clinically relevant abnormalities which may affect patient safety or interpretation of study results.
    18. A patient with a first-degree relative with a hereditary immunodeficiency.
    19. A patient with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell
    cancer of the skin or cervical carcinoma in situ.
    20. Significant trauma or major surgery within 1 month of screening visit.
    21. A patient requiring prohibited concomitant medications including prohibited dietary supplements.
    22. A patient known to be infected with human immunodeficiency virus (HIV) or hepatitis B or C virus.
    23. A patient who has previously participated in any study of CP-690,550.
    24. Participation in studies of other investigational compounds within 4 weeks or 5 half-lives (whichever is longer) prior to the first dose of study drug. Patients cannot participate in studies of other investigational compounds at any time during their participation in this study. Exposure to investigational biologics should be discussed with the Pfizer Medical Monitor.
    25. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
    E.5 End points
    E.5.1Primary end point(s)
    Multiple endpoints will be evaluated during the study to meet the stated objectives.
    Signs and Symptoms
    • ACR20 responder rates analyzed at all timepoints;
    • ACR50 and ACR70 responder rates at all timepoints;
    • DAS 28-3 and DAS 28-4 (CRP) at all timepoints;
    • DAS 28-3 and DAS 28-4 (ESR) at baseline, 3 months, 6 months and 12 months at participating sites (dependent upon availability of a local laboratory that can report ESR results directly to the central laboratory, to ensure blinding of data).
    Physical Function and Patient Reported Outcomes
    • Assessed at Baseline, Week 2 and Months 1, 2, 3, 4.5, 6, 9, and 12 / Early Termination:
    • Health Assessment Questionnaire – Disability Index;
    • Patient Assessment of Arthritis Pain;
    • Patient Global Assessment of Arthritis;
    • Physician Global Assessment of Arthritis.
    • Assessed at Baseline, and Months 1, 3, 6, 9, and 12 / Early Termination:
    • SF-36 (Version 2, Acute).
    • Assessed at Baseline and Months 1, 3, 6, and 12 / Early Termination:
    • MOS Sleep Scale;
    • FACIT – Fatigue Scale.
    • Assessed at Baseline and Months 3, 6, and 12 / Early Termination:
    • Euro Qol EQ-5D;
    • RA Healthcare Resource Utilization Questionnaire;
    • Work Limitations Questionnaire.
    Safety Endpoints
    All safety data will be summarized descriptively through appropriate data tabulations,
    descriptive statistics, and graphical presentations, including:
    • Incidence and severity of adverse events;
    • Incidence and severity of clinical laboratory abnormalities;
    • Summary of changes in physical examination compared to baseline by patient;
    • Mean change from baseline in vital signs (blood pressure, heart rate, and temperature) measurements.
    Exploratory Endpoints
    • Number of days required for a >1 day sequential (2 or more consecutive days) decrease in:
    • Patient Assessment of Arthritis Pain;
    • Patient Global Assessment of Arthritis.
    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 Yes
    E.6.13.1Other scope of the trial description
    Molecular Profiling Supplement (optional)
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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.8.3 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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA70
    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
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days11
    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.1.3Elderly (>=65 years) Yes
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Legally acceptable representative can give consent on behalf of the patient.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 350
    F.4.2.2In the whole clinical trial 750
    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)
    Follow up for clinically significant, treatment-emergent abnormalities or abnormal laboratory events are described in the protocol. Additionally, after completing study A3921046, patients may be eligible to continue treatment with CP-690,550 in open label study A3921024 (EudraCT No 2006-005035-19). Patients who have taken at least one dose of CP-690,550 and have discontinued may be eligible to enter A3921029, a non-interventional follow up study (EudraCT No 2006-006373-25).
    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 Decision2009-05-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-05-27
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-01-17
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