A PHASE IIA, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, WORLDWIDE, PROOF-OF-CONCEPT CLINICAL TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF MK-8457 IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS AND AN INADEQUATE RESPONSE OR INTOLERANCE TO ANTI-TNF-α THERAPY.

MERCK SHARP & DOHME PERU S.R.L.,0 个研究点目标入组 0 人开始时间: 2012年11月15日最近更新: 2023年9月4日

试验速览

暂无简介。

•1. SUBJECT MUST BE ≥ 18 YEARS OF AGE ON THE DAY OF SIGNING THE INFORMED CONSENT.
•RA DIAGNOSIS AND DISEASE ACTIVITY:
•2. 2.SUBJECT HAS A DIAGNOSIS OF RA (ACCORDING TO REVISED 1987 CRITERIA OF THE ARA) FOR AT LEAST 6 MONTHS PRIOR TO SCREENING (SEE APPENDIX 6.3).
•3. 3.SUBJECT HAS ACTIVE RA AS DEFINED BY THE PRESENCE OF SWOLLEN JOINTS (OF 66 JOINT
•COUNT) AND ≥ 6 TENDER JOINTS (OF 68 JOINT COUNT) AT SCREENING (VISIT 1) AND BASELINE
•(VISIT 2).
•4. SUBJECT HAS A C-REACTIVE PROTEIN (CRP) BLOOD LEVEL >0.9 MG/DL FROM THE CENTRAL REFERENCE LABORATORY AT SCREENING (SEE APPENDIX 6.3).
•5. SUBJECT IS ANTI-CITRULLINATED PROTEIN ANTIBODY (ACPA) POSITIVE AND/OR RHEUMATOID FACTOR POSITIVE AT SCREENING (SEE APPENDIX 6.3).
•6. SUBJECT IS ACR FUNCTIONAL CLASS I, II, OR III (SEE APPENDIX 6.4).
•7. SUBJECT MUST HAVE RECEIVED MTX FOR A MINIMUM OF 3 MONTHS PRIOR TO SCREENING WITH A REGIONALLY APPROPRIATE STABLE WEEKLY DOSE FOR AT LEAST 4 WEEKS PRIOR TO SCREENING (15-25 MG/WK FOR REGIONS OUTSIDE OF ASIA, AND 6-25 MG/WEEK FOR ASIA). THE SUBJECT´S DOSE OF WEEKLY MTX MUST REMAIN STABLE THROUGH WEEK 24 OF THE STUDY.
•8. SUBJECT MUST HAVE EITHER FAILED TREATMENT WITH 1 OR 2 ANTI-TNF-A THERAPIES OR WAS INTOLERANT TO ANTI-TNF-A THERAPY PRIOR TO SCREENING. FOR SUBJECTS WHO HAVE FAILED THERAPY, THE TREATMENT WITH ANTI-TNF-A THERAPIES MUST HAVE BEEN FOR AT LEAST 3 MONTHS.

•1. SUBJECT HAS INFLAMMATORY DISEASE OTHER THAN RA, INCLUDING BUT NOT LIMITED TO PSORIATIC ARTHRITIS, ANKYLOSING SPONDYLITIS, SYSTEMIC LUPUS ERYTHEMATOSUS, OR LYME DISEASE.
•2. SUBJECT WHO HAS SIGNS OR SYMPTOMS OF SEVERE, PROGRESSIVE, OR UNCONTROLLED RENAL, HEPATIC, HEMATOLOGIC, ENDOCRINE, PULMONARY, CARDIAC, NEUROLOGIC, OR CEREBRAL DISEASE, THAT AFFECTS THE SUBJECT’S ABILITY TO PARTICIPE IN THE TRIAL.
•3. SUBJECT HAS BEEN HOSPITALIZED DUE TO AN ACUTE CARDIOVASCULAR EVENT, CARDIOVASCULAR ILLNESS OR CARDIOVASCULAR SURGERY WITHIN 6 MONTHS OF SCREENING.
•4. SUBJECT HAS SUSTAINED, UNCONTROLLED HYPERTENSION (SYSTOLIC BLOOD PRESSURE OF _160 MM HG AND/OR DIASTOLIC BLOOD PRESSURE OF ._.100 MM HG AT BASELINE), OR UNCONTROLLED DIABETES.
•5. SUBJECT WHO HAS A TRANSPLANTED ORGAN, EXCLUDING CORNEAL TRANSPLANT PERFORMED >3 MONTHS PRIOR TO FIRST DOSE OF TRIAL MEDICATION.
•6. SUBJECT HAS HAD A PRIOR MALIGNANCY OR CONCURRENT MALIGNANCY (EXCLUDING SUCCESSFULLY TREATED BASAL CELL CARCINOMA, SQUAMOUS CELL CARCINOMA OF THE SKIN IN SITU, SQUAMOUS CELL CARCINOMA WITH NO EVIDENCE OF RECURRENCE WITHIN 5 YEARS, OR CARCINOMA IN SITU OF THE CERVIX THAT HAS BEEN ADEQUATELY TREATED).

发起方

MERCK SHARP & DOHME PERU S.R.L.,