A 24-WEEK, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, PLACEBO-CONTROLLED, PHASE 2 STUDY OF DIFFERENT DOSES OF VX509 IN ADULT SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS ON STABLE METHOTREXATE THERAPY WITH 104-WEEK OPEN LABEL EXTENSIO

Vertex Pharmaceuticals Incorporated,0 个研究点目标入组 0 人开始时间: 2012年10月22日最近更新: 2023年9月4日

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•1. MALE AND FEMALE SUBJECTS, BETWEEN 18 AND 80 YEARS OF AGE (INCLUSIVE) AT TIME OF CONSENT, WHO AGREE TO STUDY PARTICIPATION AND ARE ABLE TO READ, UNDERSTAND, SIGN, AND DATE A WRITTEN INFORMED CONSENT FORM (ICF).
•2. ALL SUBJECTS MUST HAVE BEEN DIAGNOSED WITH RA, AS DEFINED BY THE ACR REVISED CRITERIA (SECTION 16.1), WITH DISEASE DURATION AT SCREENING OF AT LEAST 24 WEEKS FROM THE CONFIRMED DIAGNOSIS DATE.
•3. SUBJECTS MUST HAVE DEMONSTRATED AN INADEQUATE RESPONSE TO METHOTREXATE (MTX) BY HAVING A SWOLLEN JOINT COUNT OF ≥ 6 OUT OF 66 JOINTS AND TENDER JOINT COUNT OF ≥ 6 OUT OF 68 JOINTS. JOINTS THAT HAVE HAD PRIOR SURGERY ARE TO BE EXCLUDED FROM THE JOINT COUNT.
•4. BASELINE CRP LEVEL MUST BE ABOVE THE UPPER LIMIT OF NORMAL AT SCREENING.
•5. ALL SUBJECTS MUST HAVE BEEN RECEIVING MTX COADMINISTERED WITH FOLIC OF FOLINIC ACID (AT LEAST 5 MG/WEEK) FOR AT LEAST 12 WEEKS BEFORE SCREENING DURING WHICH THE SUBJECTS MUST HAVE BEEN ON A STABLE DOSE (BETWEEN 10 MG AND 25 MG [ORALLY OR SUBCUTANEOUSLY ADMINISTERED] PER WEEK) OF MTX FOR AT LEAST 8 CONSECUTIVE WEEKS. SUBJECTS MUST NOT BE TAKING ANY CONCOMITANT DMARDS (WITH THE EXCEPTION OF HYDROCYCHLOROQUINE) OTHER THAN A STABLE DOSE OF BACKGROUND MTX. SUBJECTS ON STABLE DOSES OF HYDROCYCHLOROQUINE MAY REMAIN ON IT FOR THE DURATION OF THE STUDY. IF SUBJECTS DISCONTINUE HYDROCYCHLOROQUINE THEY MUST HAVE A WASHOUT PERIOD OF AT LEAST 14 DAYS PRIOR TO DOSING.

•1. SUBJECTS WITH INFLAMMATORY, RHEUMATOLOGICAL DISORDERS OTHER THAN RA, WHERE ARTHRITIS MAY BE A PROMINENT FEATURE, SUCH AS SYSTEMIC LUPUS ERYTHEMATOSUS, MIXED CONNECTIVE TISSUE DISEASE, SCLERODEMA, POLY/DERMATOMYOSITIS, OR SJOGREN’S SYNDROME, WILL BE EXCLUDED. SUBJECTS WITH RA WHO HAVE CONDITIONS ASSOCIATED SECONDARILY WITH RA (E.G., OSTEOARTHRITIS OF AFFECTED JOINT [S] OR SICCA SYNDROME) ARE ELEGIBLE FOR ENROLLMENT.
•2. PREGNANT OR NURSING FEMALE SUBJECTS; FEMALE SUBJECTS OF CHILDBEARING POTENTIAL WHO ARE UNWILLING OR UNABLE TO USE AN ACCEPTABLE METHOD OF NONHORMONAL CONTRACEPTION AS OUTLINED IN THIS PROTOCOL FROM AT LEAST 14 DAYS PRIOR TO THE FIRST DOSE OF STUDY DRUG.
•3. SUBJECTS WHO HAVE A FEMALE PARTNER WHO IS PREGNANT, NURSING, OR PLANING TO BECOME PREGNANT DURING THE STUDY OR WITHIN 90 DAYS OF THE LAST VX-509 DOSE.
•4. HISTORY OR EVIDENCE OF A CLINICALLY SIGNIFICANT MEDICAL DISORDER OTHER THAN RA (INCLUDING, BUT NOT LIMITED TO, CARDIOPULMONARY. ONCOLOGIC, RENAL, METABOLIC, HEMATOLOGIC OR PSYCHIATRIC DISORDERS), OR A CONDITION OR DISEASE THAT, IN THE OPINION OF THE INVESTIGATOR AND MEDICAL MONITOR, WOULD POSE A RISK TO SUBJECT SAFETY OR INTERFERE WITH THE STUDY EVALUATION, PROCEDURES, OR COMPLETION. SUBJECTS WITH A HISTORY OF CANCER, EXCEPT SQUAMOUS CELL CANCERS OF THE SKIN OR IN SITU CANCER OF THE CERVIX, ARE NOT ELEGIBLE.

发起方

Vertex Pharmaceuticals Incorporated,