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    The EU Clinical Trials Register currently displays   39188   clinical trials with a EudraCT protocol, of which   6421   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-007788-17
    Sponsor's Protocol Code Number:A3921045
    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:2009-04-08
    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 number2008-007788-17
    A.3Full title of the trial
    PHASE 3, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF CP 690,550 MONOTHERAPY IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS
    A.4.1Sponsor's protocol code numberA3921045
    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., 235 East 42nd Street, New York, NY 10017
    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.3.1Product nameCP-690,550
    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-690,550-10
    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
    CP 690,550 is being studied as a DMARD for the treatment of moderate to severe active RA in adults.
    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, as monotherapy, in doses of 5 mg BID and 10 mg BID versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA), in subjects with RA who have had an inadequate response to a DMARD (traditional or biologic), as measured by ACR20 response rates at Month 3.
    2. To compare physical function status of patients with active RA after administration of CP 690,550, as monotherapy, in doses of 5 mg BID and 10 mg BID versus placebo, as measured by the HAQ DI response at Month 3.
    3. To compare the rate of achieving DAS28-4(ESR) <2.6 at Month 3 in patients with
    active RA after administration of CP-690,550, as monotherapy, in doses of 5 mg BID
    and 10 mg BID versus placebo.
    4. To compare the safety of two doses of CP 690,550 monotherapy versus placebo monotherapy in patients with RA.
    E.2.2Secondary objectives of the trial
    1. To compare the incidence of DAS 28 remission and low disease activity state at each visit.
    2. 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
    1. Evidence of a signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
    2. Patients must be at least 18 years of age.
    3. 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 study.
    4. The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
    5. The patient has active disease at both Screening and Baseline, as defined by both: a. ≥6 joints tender or painful on motion; AND b. ≥6 joints swollen and fulfills 1 of the following 2 criteria at Screening: 1. ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory.
    6. The patient meets ACR 1991 Revised Criteria for Global Functional Status in RA,10 Class I, II or III.
    7. 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 negative Mantoux PPD skin test using 5 TU PPD (<5 mm of induration performed within the 3 months prior to screening).
    • A chest radiograph(CXR) within the 3 months prior to screening without changes suggestive of active TB infection.
    • No hx of either untreated or inadequately treated latent or active TB infection.
    • If a patient has previously received acceptable treatment for either latent or active TB infection, only a CXR need be obtained, if not done within the prior 3 months. A patient who is currently being treated for either latent or active TB infection can only be enrolled with prior approval by the Sponsor.
    8. Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
    9. For traditional DMARDS, the following minimum washout criteria apply:
    • Methotrexate, Minocycline, Penicillamine, Sulfasalazine: must have been discontinued for 4 weeks prior to the first dose of study drug.
    • Leflunomide (Arava®) must have been discontinued 8 weeks prior to the first dose of study drug if no elimination procedure is followed. Alternately, it should have been discontinued with the following elimination procedure at least 4 weeks prior to the first dose of study drug: Cholestyramine at a dosage of 8 grams three times daily for at least 24 hours, or activated charcoal at a dosage of 50 grams 4 times a day for at least 24 hours.
    • Auranofin (Ridaura®), Injectable Gold (aurothiglucose or aurothiomalate): must have been discontinued for 8 weeks prior to first dose of study drug.
    • Antimalarials (Hydroxychloroquine, Chloroquine): Antimalarials will be allowed in this study. If discontinued, they must discontinued for 4 weeks prior to the first dose of study drug. If continued, the dose must be stable for at least 8 weeks prior to first dose of study drug.
    10. Biologic Response Modifiers. All must be discontinued for entry into this study:
    • Anakinra (Kineret®), Enbrel (Etanercept®): Discontinued 4 weeks prior to the first dose of study drug;
    • Adalimumab (Humira®): Discontinued for 6 weeks prior to first dose of study drug;
    • Infliximab (Remicade®): Discontinued 8 weeks prior to the first dose of study drug;
    • Certolizumab pegol (CimziaTM), Golimumab (SimponiTM) must be discontinued for 10 weeks prior to the first dose of study drug;
    • Abatacept (Orencia®), Tocilizumab (Actemra®): Discontinued 12 weeks prior to first dose of study drug;
    • Rituximab or other selective B lymphocyte depleting agents (both marketed or investigational): Discontinued for 1 year prior to the first dose of study drug and if CD19/20+ counts are normal by FACS analysis.
    11. Other:
    a. Oral corticosteroids: Patients who are already on oral corticosteroids must be on a stable dose of ≤10 mg/day of prednisone or equivalent for 4 weeks prior to first dose of study drug.
    b. Intraarticular, intramuscular, or intravenous corticosteroids: None may be administered within 4 weeks prior to first dose of study drug.
    c. Cyclosporine, Tacrolimus, Azathioprine: All must be discontinued 4 weeks prior to the first dose of study drug.
    d. Prosorba Device/Column: This must be discontinued 4 weeks prior to the first dose of study drug.
    e. Experimental NSAIDS (including Cox 2 inhibitors): These must be discontinued 4 weeks prior to the first dose of study drug.
    f. Any investigational or marketed treatment not mentioned elsewhere must be discontinued for 4 weeks or 5 half lives, whichever is longer. Exposure to investigational biologics should be discussed with the Sponsor.
    12. Patients receiving non prohibited concomitant medications for any reason must be willing to stay on a stable regimen.
    E.4Principal exclusion criteria
    1. Any prior treatment with non B lymphocyte selective lymphocyte depleting agents/therapies, such as alemtuzumab (Campath®) OR alkylating agents (eg, cyclophosphamide or chlorambucil) OR total lymphoid irradiation, etc.
    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 of 9/L;
    • Absolute neutrophil count <1.2 x 10 to the power of 9/L;
    • Platelet count <100 x 10 to the power of 9/L.
    4. Estimated GFR ≤40 ml/min based on Cockcroft Gault calculation.
    5. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening visit.
    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 autoimmune rheumatic 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 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.
    11. History of any infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug.
    12. A history of recurrent (more than one episode) herpes zoster, disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    13. A patient who was vaccinated or exposed to a live or attenuated vaccine within the 6 weeks prior to the first dose of study drug, expects to be vaccinated or exposed to these vaccines during treatment, or during the 6 weeks following discontinuation of study drug.
    14. 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.
    15. History of alcohol or drug abuse with less than 6 months of abstinence prior to first dose of study drug.
    16. Screening 12 lead ECG that demonstrates clinically relevant abnormalities which may affect patient safety or interpretation of study results.
    17. A patient with a first degree relative with a hereditary immunodeficiency.
    18. 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.
    19. Significant trauma or major surgery within 1 month of screening visit.
    20. A patient requiring prohibited concomitant medications including prohibited dietary supplements.
    21. A patient infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses.
    22. A patient who has previously participated in any study of CP 690,550.
    23. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug 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.
    24. A patient who, in the opinion of the Investigator or Pfizer, will be uncooperative or unable to comply with study procedures. This includes patients who are blind or
    otherwise unable to complete a visual analog scale (VAS).
    E.5 End points
    E.5.1Primary end point(s)
    1. American College of Rheumatology 20 (ACR20) responder rate versus placebo at the Month 3 visit.
    2. Change from baseline in the Health Assessment Questionnaire (HAQ DI) at the Month 3 visit.
    3. Rate of patients achieving a DAS28-4(ESR) <2.6 versus placebo at the Month 3 visit.
    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 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.8.3 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA28
    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
    End of trial is LSLV
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 140
    F.4.2.2In the whole clinical trial 611
    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 A3921045, patients may be eligible to continue treatment with CP-690,550 in open label study A3921024 (EudraCT No 2006-005035-19).
    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 Decision2009-05-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-06-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-06-23
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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