Rheumatoid Arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Sponsors
Rigel Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients must give written informed consent by signing an IRB/EC-approved Informed Consent Form (ICF) prior to admission to this study. 2) Males and females, 18 years of age or older, with active RA for at least 6 months prior to Day 1 dosing (functional class I–III, e.g., not bed or wheelchair-bound). Active RA is defined as the presence of (a) = 6 swollen joints (28 joint count); AND (b) = 6 tender joints (28 joint count); AND at least one of the following (c) ESR >28 mm/hr or CRP >ULN for the central reference laboratory. 3) Patients must have been receiving weekly MTX doses (7.5–25 mg/week) for a minimum of 3 months prior to Day 1 dosing and must be receiving a stable MTX dose, with no change in route, for the previous 6 weeks prior to Day 1 dosing. If the current MTX dose is =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) The patient has a history of, or a concurrent, clinically significant illness, medical condition (other than arthritis) or laboratory abnormality that, in the Investigator’s opinion, could affect the conduct of the study. Specifically, excluded are patients with the following: a) uncontrolled or poorly controlled hypertension; b) other autoimmune disease (psoriatic arthritis, lupus, mixed connective disorder) or arthritis syndromes (gout, Lyme disease, Reiter’s syndrome); c) recent (within past 2 months prior to Day 1 dosing) serious surgery or infectious disease; d) recent history (past 5 years prior to Day 1 dosing) of, or treatment for, a malignancy other than nonmelanomatous skin cancer, or any history of lymphoma; e) Hepatitis B surface antigen positive; f) Hepatitis C antibody positive; may be included if Hepatitis C RIBA negative or HCV RNA negative (qualitative); g) interstitial pneumonitis or active pulmonary infection on chest x-ray (taken within 1 month prior to screening); h) Tuberculosis (TB): the TB skin test should be negative (if the patient was never vaccinated, or if vaccinated more than 10 years ago; in this context negative means 1.2x ULN, creatinine >1.5x ULN, an ANC < 2,500/mm3 or lymphocyte count < 600/mm3, Hgb <9 g/dL, platelet count < 125,000/mm3 are excluded. 2) The patient has a history of substance abuse, drug addiction or alcoholism. Patients may consume up to 4 units of alcohol per week; however, alcohol should be avoided in the 72 hours prior to lab assessments. Patients who cannot reliably comply with this should be excluded. A unit of alcohol is defined as the following: Beer=12 oz or 355 mL; wine = 5 oz or 148 mL; sweet dessert wine=3 oz or 89 mL; 80 proof distilled spirits= 1.5 oz or 44 mL. 3) The patient has been treated previously treated with R788 under a different protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy objective of this study is to confirm the efficacy of R788 100 mg PO bid as determined by ACR20 responder rates at 6 months.;Secondary Objective: The secondary efficacy objectives of this study are as follows: 1) To compare response rates for R788 100 mg PO bid and R788 150 mg PO qd as determined by ACR20, ACR50, ACR70, ACRn, DAS28-CRP and DAS28-ESR response rates over 6 months; 2) To assess the rapidity of onset of clinical effect among the R788 100 mg PO bid, R788 150 mg PO qd, and placebo groups as determined by ACR20 response rates at Weeks 1 and 2; 3) To compare changes for R788 100 mg PO bid and R788 150 mg PO qd in the FACIT-fatigue and SF-36 from baseline to 6 months; 4) To assess and compare the safety profiles for R788 100 mg PO bid and R788 150 mg PO qd compared with placebo for effects on liver function tests, clinically significant reductions in peripheral neutrophil counts, G-I side effects and other adverse effects as they may appear. ;Primary end point(s): The Primary Efficacy parameter is ACR20 response rate at Month 6 post dosing. A patient will be defined as an ACR responder if he or she shows at least 20% improvement from baseline in both tender and swollen joint counts, and at least 20% improvement in any 3 of the following 5 criteria: 1) Physician global assessment of disease activity (VAS) 2) Patient global assessment of disease activity (VAS) 3) Patient reported pain score (VAS) 4) Health Assessment Questionnaire Disability Index (HAQ-DI) 5) C-reactive protein (CRP) or ESR | — |
Countries
Bulgaria, Hungary, Poland
Outcome results
None listed