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An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis (RA-BEYOND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01885078
Recruitment Status : Recruiting
First Posted : June 24, 2013
Last Update Posted : October 17, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 19, 2013
First Posted Date  ICMJE June 24, 2013
Last Update Posted Date October 17, 2019
Actual Study Start Date  ICMJE June 27, 2013
Estimated Primary Completion Date February 14, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
Number of Participants (pts) with One or More Drug Related Adverse Events (AEs) or any Serious AEs [ Time Frame: Baseline through 84 Months ]
Original Primary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
Number of Participants with One or More Drug Related Adverse Events (AEs) or any Serious AEs [ Time Frame: Baseline through 2 Years ]
Change History Complete list of historical versions of study NCT01885078 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 11, 2018)
  • Proportion of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20, ACR50, and ACR70 [ Time Frame: Months 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  • Proportion of Pts 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, and ACR/European League Against Rheumatism Remission [ Time Frame: Months 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  • Change from Baseline of Originating Study in Modified Total Sharp Score (mTSS) [ Time Frame: Baseline, Month 12, 24, 36, 48 and 60 ]
  • Proportion of Participants with mTSS change ≤0 [ Time Frame: Baseline, Months 12, 24, 36, 48 and 60 ]
  • Change from Baseline of Originating Study in Joint Space Narrowing [ Time Frame: Baseline, Month 12, 24, 36, 48 and 60 ]
  • Change from Baseline of Originating Study in Duration of Morning Stiffness [ Time Frame: Baseline, Month 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  • Change from Baseline or Originating Study in European Quality of Life-5 Dimensions-5 Level (EQ-5D-5L) Scores [ Time Frame: Baseline, Months 66, 72, 90, 102 and 114 ]
  • Proportion of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10 and ≤2.8 [ Time Frame: Months 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  • Proportion of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement ≥0.22 and ≥0.3 [ Time Frame: Months 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  • Change from Baseline in Bone Erosion Score [ Time Frame: Baseline, Month 12, 24, 36, 48, and 60 ]
  • Healthcare Resource Utilization [ Time Frame: Baseline through Months 66, 72, 90, 102 and 114 ]
  • Proportion of Participants Maintaining a Simplified Disease Activity Index (SDAI) ≤11 and ≤3.3 [ Time Frame: Months 6, 12, 24, 36, 48, 54, 60, 72, 78, 84, 90, 102 and 114 ]
  • Time to Relapse [ Time Frame: Baseline through Month 114 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2013)
  • Proportion of Participants Maintaining an American College of Rheumatology (ACR) Response of ACR20, ACR50, and ACR70 [ Time Frame: Baseline through Months 12, 24, 36, 48, 54 ]
  • Proportion of Participants Maintaining a Disease Activity Score (DAS28) high-sensitivity C-Reactive Protein (hsCRP)/DAS28-Erythrocyte Sedimentation Rate (ESR) ≤3.2 [ Time Frame: Baseline through Months 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 through 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, 2 Years ]
  • Proportion of Participants Maintaining a Clinical Disease Activity Index Score (CDAI) ≤10 [ Time Frame: Baseline through Months 12, 24, 36, 48, 54 ]
  • Proportion of Participants Maintaining a Health Assessment Questionnaire Disability Index (HAQ-DI) Improvement of ≥0.22 and ≥0.3 [ Time Frame: Baseline through Months 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 2 Years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE An Extension Study in Participants With Moderate to Severe Rheumatoid Arthritis
Official Title  ICMJE A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
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 study provides for 7 years of additional treatment with baricitinib.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Baricitinib
    Administered orally
    Other Names:
    • LY 3009104
    • INCB 028050
  • Drug: Placebo
    Administered orally
Study Arms  ICMJE
  • Experimental: Baricitinib 4 mg

    Baricitinib 4 milligrams (mg) administered orally once daily throughout the 84 month treatment period. Placebo administered orally to maintain blind.

    Participants may continue to receive the background non-investigational, open-label conventional disease-modifying antirheumatic drugs (cDMARD), nonsteroidal anti-inflammatory drug (NSAID), corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

    Interventions:
    • Drug: Baricitinib
    • Drug: Placebo
  • Experimental: Baricitinib 2 mg

    Baricitinib 2 mg administered orally once daily throughout the 84 month treatment period. Placebo administered orally to maintain blind.

    Participants may continue to receive the background non-investigational, open-label cDMARD, NSAID, corticosteroid, and other analgesic therapies they were receiving at completion of the originating study.

    Interventions:
    • Drug: Baricitinib
    • Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 14, 2017)
2944
Original Estimated Enrollment  ICMJE
 (submitted: June 19, 2013)
2347
Estimated Study Completion Date  ICMJE March 22, 2024
Estimated Primary Completion Date February 14, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Have completed the final active treatment in study JADV (NCT01710358), JADZ (NCT01711359), JADX (NCT01721057), JADW (NCT01721044), JADA (NCT01185353) or JAGS (planned start date in August 2014)

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Croatia,   Czechia,   Denmark,   France,   Germany,   Greece,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Mexico,   Netherlands,   Poland,   Portugal,   Puerto Rico,   Romania,   Russian Federation,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom,   United States
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number  ICMJE NCT01885078
Other Study ID Numbers  ICMJE 14060
I4V-MC-JADY ( Other Identifier: Eli Lilly and Company )
2012-003686-17 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date October 15, 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP