None listed
Conditions
Interventions
THOSE RANDOMISED PATIENTS WHO HAVE BEEN IN PART B EFC11072 IN A GROUP OF TREATMENT AFTER NOT KEPT AFTER SELECTING THE PIVOT DOSE ALSO ELIGIBLE FOR RECRUITMENT. PATIENTS MUST SIGN A SPECIFIC CONSENT TO
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 101. RA PATIENTS WHO WERE RANDOMIZED STUDY IN EFC11072 (A STUDY RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED IN ACTIVE RHEUMATOID ARTHRITIS PATIENTS WHO HAD AN INADEQUATE RESPONSE TO THERAPY WITH MTX). • AND WHO HAVE COMPLETED PART A (12 WEEKS) OR PART B (52 WEEKS) EFC11072 STUDY. • RANDOMIZED PATIENTS IN THE STUDY PART B EFC11072 ARM TREATMENT TO A SUBSEQUENTLY NOT KEPT AFTER THE PIVOTAL DOSE SELECTION. • RA PATIENTS WHO WERE RANDOMIZED TO AND ENDED ACT11575 TREATMENT PERIOD. 102. MUST SIGN PATIENT INFORMED CONSENT TO PARTICIPATE IN THE STUDY LTS1121 OR PRIOR TO ANY PROCEEDING RELATING TO THE STUDY.
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA RELATED THERAPIES MANDATORY BACKGROUND E01. PATIENTS WHO DO NOT WANT TO CONTINUE TAKING FOLIC ACID 5 MG WEEKLY OR OLDER WITH DOSE OF MTX, TO MINIMIZE THE TOXICITY. E02. CONTRAINDICATION ANY PATIENTS ACCORDING TO MTX SMPC TRIAL INVESTIGATOR OR. EXCLUSION CRITERIA RELATED COMPOUND SANOFI-AVENTIS: E03. ANY PATIENT WHO HAS EXPERIENCED AN ADVERSE EVENT THAT LED TO THE DISCONTINUANCE OF EFC11072. E04. ABNORMAL OR ANY ADVERSE EVENTS IN THE SELECTION (THE LAST VISIT EFC11072 TREATMENT STUDY SELECTION WILL VISIT) TRIAL INVESTIGATOR THAT COULD ADVERSELY AFFECT PATIENT PARTICIPATION IN THIS STUDY EXAMPLES: E05. SUBJECTS WITH ACTIVE TB VISIT OR LOSS IN THE END OF TREATMENT IN THE STUDIO OR ACT11575 EFC11072. E06. PREGNANT OR BREASTFEEDING E07. WOMEN OF REPRODUCTIVE AGE (WOCBP), NOT WILLING TO USE A PROPER BIRTH CONTROL OR NOT PREGNANT DURING THE COURSE OF STUDY TOTAL. INCLUDE APPROPRIATE MEASURES ORAL CONTRACEPTIVE AND OTHER PHARMACEUTICAL PRESCRIPTION BIRTH CONTROL (USE STABLE CYCLES FOR 2 OR MORE BEFORE THE SELECTION) IUD; LINKAGE BILATERAL HORN, Vasectomy, DOUBLE BARRIER: CONDOM OR MORE SPONGE DIAPHRAGM, FOAM OR GEL CONTRACEPTIVE.
Countries
Argentina, Australia, Brazil, Canada, Chile, Colombia, Estonia, Finland, Germany, Greece, Hungary, Korea North, Lithuania, Malasya, Mexico, New Zealand, Poland, Romania, Russian Federation, South Africa, Spain, Ukraine, United States
Contacts
Public ContactCarolina Valladares
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed