An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
- Conditions
- Patients with Moderately to Severely Active Rheumatoid Arthritis
- Registration Number
- CTRI/2014/07/004736
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The purpose of this study is to investigate the long-term safety and any side effects of baricitinib in participants who have completed a previous baricitinib rheumatoid arthritis study. The baricitinib RA studies being conducted in India are I4V-MC-JADX (**CTRI/2013/12/004212**) and I4V-MC-JADZ (**CTRI/2013/12/004211**).
The study provides for 2 years of additional treatment with baricitinib, but may be extended to allow for continued treatment for up to 5 years after evaluation of the safety profile of baricitinib.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 2671
- Have completed the final active treatment in study JADZ with CTRI no.
- (CTRI/2013/12/004211)(NCT01711359) or JADX (NCT01721057)with CTRI no.
- (CTRI/2013/12/004212).
Have significant uncontrolled cerebro-cardiovascular (eg, myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that developed during a previous baricitinib study that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered -Have a known hypersensitivity to baricitinib or any component of this investigational product -Had investigational product permanently discontinued at any time during a previous baricitinib study -Had temporary investigational product interruption at the final study visit of a previous baricitinib study and, in the opinion of the investigator, this poses an unacceptable risk for participation in the study -Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs Time Frame: Baseline through 2 Years
- Secondary Outcome Measures
Name Time Method -Proportion of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20, ACR50, and ACR70 Time Frame: Months 6, 12, 24, 36, 48, 54 -Proportion of Participants Maintaining a Disease Activity Score (DAS28) high-sensitivity C-Reactive Protein (hsCRP) ≤3.2, DAS28-Erythrocyte Sedimentation Rate (ESR) ≤3.2, DAS28-hsCRP 2.6 and DAS28-ESR 2.6 Time Frame: Months 6, 12, 24, 36, 48, 54 -Change from Baseline in modified Total Sharp Score (mTSS) Time Frame: Baseline, Month 12, 24, 36, 48 -Proportion of Participants with mTSS change ≤0 Time Frame: Baseline, Months 12, 24, 36, 48 -Change from Baseline in Joint Space Narrowing Time Frame: Baseline, Month 12, 24, 36, 48 -Change from Baseline in Duration of Morning Stiffness Time Frame: Baseline, Month 12, 24, 36, 48, 54 -Change from Baseline in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores Time Frame: Baseline, Months 30, 36, 54 -Proportion of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10 and ≤2.8 Time Frame: Months 6, 12, 24, 36, 48, 54 -Proportion of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22 and ≥0.3 Time Frame: Months 6, 12, 24, 36, 48, 54 -Change from Baseline in Bone Erosion Score Time Frame: Baseline, Month 12, 24, 36, 48 -Healthcare Resource Utilization Time Frame: Baseline through Months 30, 36, 54 -Proportion of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11 and ≤3.3 Time Frame: Months 6, 12, 24, 36, 48, 54
Trial Locations
- Locations (18)
AMC MET Medical College and Seth LG General Hospital
🇮🇳Ahmadabad, GUJARAT, India
Apollo Gleneagles Hospitals
🇮🇳Kolkata, WEST BENGAL, India
Gurunanak Care Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Indraprastha Apollo Hospitals
🇮🇳East, DELHI, India
Institute of Postgraduate Medical Education and Research
🇮🇳Kolkata, WEST BENGAL, India
K.L.E.S Dr. Prabhakar Kore Hospital and MRC
🇮🇳Belgaum, KARNATAKA, India
King George Medical College
🇮🇳Lucknow, UTTAR PRADESH, India
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
🇮🇳Mumbai, MAHARASHTRA, India
Krishna Institute of Medical Sciences
🇮🇳Hyderabad, ANDHRA PRADESH, India
M S Ramaiah Medical College & Hospital
🇮🇳Bangalore, KARNATAKA, India
Scroll for more (8 remaining)AMC MET Medical College and Seth LG General Hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Piyush ParikhPrincipal investigator079-25472101pnparikhlg@gmail.com