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Trial record 2 of 11 for:    Baricitinib AND Rheumatoid Arthritis

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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01885078
First Posted: June 24, 2013
Last Update Posted: October 5, 2017
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. Read our disclaimer for details.
Information provided by (Responsible Party):
Eli Lilly and Company
  Purpose

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 5 years of additional treatment with baricitinib.


Condition Intervention Phase
Rheumatoid Arthritis Drug: Baricitinib Drug: Placebo Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Number of Participants (pts) with One or More Drug Related Adverse Events (AEs) or any Serious AEs [ Time Frame: Baseline through 60 Months ]

Secondary Outcome Measures:
  • 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, and 90 ]
  • 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, and 90 ]
  • 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, and 90 ]
  • 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, and 90 ]
  • 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, and 90 ]
  • 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, and 90 ]
  • 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, and 90 ]
  • 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, and 90 ]
  • Time to Relapse [ Time Frame: Baseline through Month 90 ]

Estimated Enrollment: 2944
Study Start Date: June 2013
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Baricitinib 4 mg

Baricitinib 4 milligrams (mg) administered orally once daily throughout the 60 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 60 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

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 Submitted: June 19, 2013
First Posted: June 24, 2013
Last Update Posted: October 5, 2017
Last Verified: October 2017
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