A 2-Year Phase 3 Study Of CP-690,550 In Patients With Active Rheumatoid Arthritis On Background Methotrexate
- Conditions
- -M069M069
- Registration Number
- PER-072-09
- Lead Sponsor
- PFIZER S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• Active, moderate to severe, rheumatoid arthritis with joint erosions or positive IgM Rheumatoid Factor or antibodies to cyclic citrullinated peptide
• Be on an adequate and stable dose of methotrexate
• Meet all eligibility criteria outlined below.
• Meet the ACR classification criteria for the diagnosis of RA by satisfying at least four of the seven criteria.
• Have at least three distinct joint erosions on posteroanterior (PA) hand and wrist or anteroposterior (AP) foot radiographs OR if this is not available, must have a positive IgM rheumatoid factor OR antibodies to cyclic citrullinated peptide
• The patient must have active disease at both screening and baseline, as defined by having both =6 tender/painful joints on motion, and; =6 swollen joints.
• At screening must have either Erythrocyte sedimentation rate (ESR) (Westergren method) >28 mm/hr or C reactive protein (CRP) >7 mg/L
• The patient must meet Class I, II or III of the ACR 1991 Revised Criteria for Global Functional Status in RA.
• Must have taken oral or parenteral methotrexate continuously for at least 4 months and be on a stable weekly dose for at least 6 weeks. Weekly doses less than 15 mg are allowed only in the presence of intolerance or toxicity or where higher doses violate the local label. Doses higher than 25 mg weekly are not permitted.
• Be on a stable dose of folic acid not less than 5 mg weekly, unless higher doses would violate the local label, for at least 4 weeks.
• Must have an inadequate clinical response to methotrexate defined as the presence of sufficient residual disease activity to meet the entry criteria.
• Pregnancy or currently lactating.
• Blood dyscrasias, including confirmed: a. Hemoglobin <9 g/dL or Hematocrit <30%; b. White blood cell count <3.0 x 10 to the power of 9/L; c. Absolute neutrophil count <1.2 x 10 to the power of 9/L; d. Platelet count <100 x 10to the power of 9/L.
• Estimated GFR <40 ml/min based on Cockcroft Gault calculation.
• 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.
• Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, metabolic, pulmonary, cardiac, or neurological disease.
• History of any other rheumatic autoimmune disease, other than Sjogren’s syndrome
• History of an infected joint prosthesis at any time, with the prosthesis still in situ.
• 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.
• History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
• History of any 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.
• History of any infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug.
• 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.
• 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.
• 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.
• History of alcohol or drug abuse with less than 6 months of abstinence prior to first dose of study drug.
• Screening 12 lead electrocardiogram (ECG) that demonstrates clinically relevant abnormalities that may affect patient safety.
• A patient with a first degree relative with a hereditary immunodeficiency.
• 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.
• Significant trauma or surgery procedure within 1 month prior to first dose of study drug.
• A patient requiring prohibited concomitant medications including prohibited dietary
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method