A PHASE 11, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, WORLDWIDE, DOSE-RANGING CLINICAL TRIAL WITH A PROOF-OF-CONCEPT LEAD COHORT TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF MK-8457 + MTX IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS DESPITE METHOTREXATE THERAPY
- Registration Number
- PER-036-12
- Lead Sponsor
- MERCK SHARP & DOHME PERU S.R.L.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Not specified
- Target Recruitment
- 0
1. SUBJECT MUST BE ≥ 18 YEARS OF AGE ON THE DAY OF SIGNING THE INFORMED CONSENT.
RA DIAGNOSIS AND DISEASE ACTIVITY:
2. SUBJECT HAS A DIAGNOSIS OFRA (ACCORDING TO REVISED 1987 CRITERIA OFTHE ARA) FOR AT LEAST 6 MONTHS PRIOR TO SCREENING. (SEE APPENDIX 6.3)
3. SUBJECT HAS ACTIVE RA AS DEFINED BY THE PRESENCE OF 6 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-CYCLIC CITRULLINATED ANTIBODY 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. SUBJECTS HAS RECEIVED MTX FOR A MINIMUM OF 3 MONTHS WITH A REGIONALLY APPROPIATE STABLE WEEKLY DOSE (15-25 MG/WK FOR REGIONS OUTSIDE OF ASIA 6-16 MG/WEEK FOR ASIA) FOR AT LEAST 4 WKS PRIOR TO ENTERING STUDY. DOSE OF WEEKLY METHOTREXATE MUST REMAIN STABLE THROUGH WEEK 24. THE INVESTIGATOR MUST ASSESS THE SUBJECT AS HAVING AN INADEQUATE RESPONSE TO MTX.
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 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 PARTICIPATE 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, UNCONTROILED HYPERTENSION (SYSTOLIC BLOOD PRESSURE OF ≥ 160 MM HG AND/OR DIASTOLIC BLOOD PRESSURE OF ≥ 100 MM HG AT BASELINE), OR UNCONTROLLED DIABETES.
5. SUBJECTS 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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method