A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY OF THE SAFETY AND THE EFFECT ON CLINICAL OUTCOME OF TOCILIZUMAB SC VERSUS PLACEBO SC IN COMBINATION WITH TRADITIONAL DISEASE MODIFYING ANTI-RHEUMATIC DRUGS (DMARDS) IN PATIENTS WITH MODERATE TO SEVERE ACTIVE RHEUMATOID ARTHRITIS

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 0 人开始时间: 2011年8月8日最近更新: 2023年9月4日

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•1. ABLE AND WILLING TO GIVE WRITTEN INFORMED CONSENT AND COMPLY WITH THE REQUIREMENTS OF THE STUDY PROTOCOL (e.g. WILLING TO TAKE ORAL FOLATE AT A MINIMUM DOSE OF 5 MG/WEEK IF ON MTX TREATMENT.)
•2. AGE ≥ 18 YEARS.
•3. RHEUMATOID ARTHRITIS OF ≥ 6 MONTHS DURATION, DIAGNOSED ACCORDING TO THE REVISED 1987 AMERICAN COLLEGE OF RHEUMATOLOGY (ACR; FORMERLY AMERICAN RHEUMATISM ASSOCIATION CRITERIA, APPENDIX 2).
•4. RECEIVING TREATMENT ON AN OUTPATIENT BASIS.
•5. SWOLLEN JOINT COUNT (SJC) ≥ 6 (66 JOINT COUNT) AND TENDER JOINT COUNT (TJC) ≥ 8 (68 JOINT COUNT) AT SCREENING AND BASELINE.
•6. PRIOR TO RANDOMIZATION, WILL HAVE DISCONTINUED ETANERCEPT FOR ≥ 2 WEEKS, INFLIXIMAB, CERTOLIZUMAB, GOLIMUMAB, ABATACEPT OR ADALIMUMAB FOR ≥ 8 WEEKS, ANAKRINA FOR ≥ 1 WEEK.
•7. HAVE TO BE ON PERMITTED DMARD(S) (SEE SECTION 4.4.2) AT A STABLE DOSE FOR AT LEAST 8 WEEKS PRIOR TO THE BASELINE
•8. AT SCREENING EITHER CRP ≥ 1 MG/DL (10 MG/L) OR ESR ≥ 28 MM/HR.
•9. AT SCREENING , RADIOGRAPHIC EVIDENCE OF AT LEAST ONE JOINT WITH A DEFINITE EROSION ATTRIBUTABLE TO RHEUMATOID ARTHRITIS, AS DETERMINED BY THE CENTRAL READING SITE. ANY JOINT OF THE HANDS, WRIST, OR FEET CAN BE CONSIDERED WITH THE EXCEPTION OF THE DIP JOINTS OF THE HANDS.

•1. MAJOR SURGERY (INCLUDING JOINT SURGERY) WITHIN 8 WEEKS PRIOR TO SCREENING VISIT OR PLANNED MAJOR SURGERY WITHIN 6 MONTHS FOLLOWING RANDOMIZATION.
•2. RHEUMATIC AUTOIMMUNE DISEASE OTHER THAN RA, INCLUDING SYSTEMIC LUPUS ERYTHEMATOSUS (SLE), MIXED CONNECTIVE TISSUE DISORDER (MCTD), SCLERODERMA, POLYMYOSITIS, OR SIGNIFICANT SYSTEMIC INVOLVEMENT SECONDARY TO RA (e.g., VASCULITIS, PULMONARY FIBROSIS OR FELTY´S SYNDROME). SECONDARY SJOGREN´S SYNDROME WITH RA IS PERMITTED.
•3. FUNCTIONAL CLASS IV, AS DEFINED BY THE ACR CLASSIFICATION OF FUNCIONAL STATUS IN RHEUMATOID ARTHRITIS (APPENDIX 3)
•4. DIAGNOSIS OF JUVENILE IDIOPATHIC ARTHRITIS (JIA) OR AR JUVENILE RHEUMATOID ARTHRITIS (JRA) AND/OR RA BEFORE THE AGE OF 16.
•5. PRIOR HISTORY OF OR CURRENT INFLAMMATORY JOINT DISEASE OTHER THAN RA (E.G., GOUT, LYME DISEASE, SERONEGATIVE SPONDYLOARTHROPATHY INCLUDING REACTIVE ARTHRITIS, PSORIATIC ARTHRITIS AND ARTHROPATHY INFLAMMATORY BOWEL DISEASE).
•EXCLUDED PREVIOUS OR CONCOMITANT THERAPY:
•6. TREATMENT WITH ANY INVESTIGATIONAL AGENT WITHIN 4 WEEKS (OR 5 HALF-LIVES OF THE INVESTIGATIONAL DRUG, WHICHEVER IS LONGER) OF SCREENING.
•7. PREVIOUS TREATMENT WITH THE FOLLOWING CELL-DEPLETING THERAPIES, INCLUDING INVESTIGATIONAL AGENTS: CAMPATH, ANTI-CD4, ANTI-CD5, ANTI-CD3, ANTI-CD19 AND ANTI CD20.

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