CTRI/2014/07/004736 [Registered on: 14/07/2014] Trial Registered Prospectively
Last Modified On:
02/12/2015
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Scientific Title of Study
A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients with Rheumatoid Arthritis
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
I4V-MC-JADY amendment c dated 31 May 2013
Protocol Number
NCT01885078
ClinicalTrials.gov
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Tarun Puri
Designation
Medical Director
Affiliation
Eli Lilly and Company India Private Limited
Address
Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32 Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32 Gurgaon HARYANA 122001 India
Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32 Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32 Gurgaon HARYANA 122001 India
Phone
0124-4753000
Fax
0124-4753013
Email
puri_tarun@lilly.com
Details of Contact Person Public Query
Name
Rajeev Sharan Shrivastava
Designation
Director-Clinical Research
Affiliation
Eli Lilly and Company India Private Limited
Address
Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32 Eli Lilly and Company India Private Limited, Plot No. 92, Sec- 32 Gurgaon HARYANA 122001 India
Phone
0124-4753000
Fax
0124-4753013
Email
shrivastava_rajeev_sharan@lilly.com
Source of Monetary or Material Support
Eli Lilly and Company
Primary Sponsor
Name
Eli Lilly and Company
Address
Corporate Center Indianapolis, IN 46285 USA
Type of Sponsor
Pharmaceutical industry-Global
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
Argentina Australia Austria Belgium Brazil Canada China Croatia Czech Republic Denmark France Germany Greece Hungary India Israel Italy Japan Latvia Lithuania Mexico Netherlands Poland Portugal Romania Russian Federation Slovakia Slovenia South Africa Spain Sweden Switzerland Taiwan Turkey United Kingdom United States of America
Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute
Department Of Rheumatology, Four Bungalows, Andheri (W) Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute – Mumbai -400053
Mumbai MAHARASHTRA
Patients with Moderately to Severely Active Rheumatoid Arthritis,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Baricitinib 2 mg
Baricitinib 2 mg administered orally once daily throughout the 24 month treatment period
Intervention
Baricitinib 4 mg
Baricitinib 4 milligrams (mg) administered orally once daily throughout the 24 month treatment period
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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)
ExclusionCriteria
Details
-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
Method of Generating Random Sequence
Method of Concealment
Pre-numbered or coded identical Containers
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
-Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs
Time Frame: Baseline through 2 Years
Secondary Outcome
Outcome
TimePoints
-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
Target Sample Size
Total Sample Size="2671" Sample Size from India="93" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
17/07/2014
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
27/06/2013
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="7" Months="7" Days="9"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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.