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

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ClinicalTrials.gov Identifier: NCT01885078
Recruitment Status : Active, not recruiting
First Posted : June 24, 2013
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
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 study provides for 7 years of additional treatment with baricitinib.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: Baricitinib Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2944 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients With Rheumatoid Arthritis
Study Start Date : June 2013
Estimated Primary Completion Date : February 2024
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Drug: Baricitinib
Administered orally
Other Names:
  • LY 3009104
  • INCB 028050
Drug: Placebo
Administered orally
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.

Drug: Baricitinib
Administered orally
Other Names:
  • LY 3009104
  • INCB 028050
Drug: Placebo
Administered orally



Primary Outcome Measures :
  1. Number of Participants (pts) with One or More Drug Related Adverse Events (AEs) or any Serious AEs [ Time Frame: Baseline through 84 Months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change from Baseline of Originating Study in Modified Total Sharp Score (mTSS) [ Time Frame: Baseline, Month 12, 24, 36, 48 and 60 ]
  4. Proportion of Participants with mTSS change ≤0 [ Time Frame: Baseline, Months 12, 24, 36, 48 and 60 ]
  5. Change from Baseline of Originating Study in Joint Space Narrowing [ Time Frame: Baseline, Month 12, 24, 36, 48 and 60 ]
  6. 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 ]
  7. 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 ]
  8. 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 ]
  9. 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 ]
  10. Change from Baseline in Bone Erosion Score [ Time Frame: Baseline, Month 12, 24, 36, 48, and 60 ]
  11. Healthcare Resource Utilization [ Time Frame: Baseline through Months 66, 72, 90, 102 and 114 ]
  12. 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 ]
  13. Time to Relapse [ Time Frame: Baseline through Month 114 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885078


  Show 405 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01885078     History of Changes
Other Study ID Numbers: 14060
I4V-MC-JADY ( Other Identifier: Eli Lilly and Company )
2012-003686-17 ( EudraCT Number )
First Posted: June 24, 2013    Key Record Dates
Last Update Posted: January 16, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases