A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLED-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF LY2127399 IN PATIENTS WITH MODERATE TO SEVERE RHEUMATOID ARTHRITIS (RA) WHO HAD AN INADEQUATE RESPONSE TO ONE OR MORE TNF-α INHIBITORS

Not Applicable

• Registration Number: PER-088-11
• Lead Sponsor: ELI LILLY AND COMPANY,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01-05
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. AMBULATORY MALES OR FEMALES ≥ 18 YEARS OF AGE.
2. DIAGNOSIS OF ADULT-ONSET RA (OF AT LEAST 6 MONTHSDURATION BUT NOT LONGER THAN 15 YEARS PRIOR TO SCREENING) AS DEFINED BY THE ARA 1987 REVISED CRITERIA FOR THE CLASSIFICATION OF RA (APPENDIX 4).
3. HAVE ACTIVE RA DEFINED AS THE PRESENCE OF AT LEAST 8/68 TENEDER AND AT LEAST 8/66 SWOLLEN JOINTS, AS DETERMINED BY THE TENDER JOINT COUNT AND SWOLLEN JOINT COUNTASESSMENT FORMS. (APPENDIX 5).
4. HAVE A SCREENING GREATER THAN 1.2 TIMES THE UPPER LIMIT OF NORMAL (ULN) OR A SCREENING ERYTHROCYTE SEDIMENTATION RATE (ESR) GREATER THAN 28 mm/hr. THESE TESTS MAY BE REPEATED ONE TIME DURING THE SCREENING PERIOD AT THE DISCRETION OF THE INVESTIGATOR.
5. DOCUMENTED HISTORY OF, OR CURRENT, POSITIVE RF AND/OR ANTI-CCP AB TEST.
6. PATIENTS MUST HAVE BEEN TREATED AT APPROVED DOSES WITH AT LEAST ONE BIOLOGIC TNF-α INHIBITOR THERAPY (INFLIXIMAB, CERTOLIZUMAB, GOLIMUMAB, ETANERCEPT, ADALIMUMAB) AND IN THE OPINION OF THE INVESTIGATOR EITHER:
A. STOPPED DUE TO INSUFFICIENT EFFICACY, OR LOSS OF EFFICACY, AFTER AT LEAST 90 DAYS OF TREATMENT,
OR
B. STOPPED DUE TO INTOLERANCE OF SUCH TREATMENT, REGARDLESS OF TREATMENT DURATION.

Exclusion Criteria

1. USE OF AN UNSTABLE DOSE (ie., REQUIRING DOSE ADJUSTMENT) OF NSAIDs (INCLUDING CYCLOOXYGENASE-2 [COX-2] INHIBITORS) WITHIN 6 WEEKS PRIOR TO BASELINE (VISIT 2).
2. USE OF ORAL CORTICOSTEROIDS AT AVERAGE DAILY DOSE OF > 10 mg/day OF PREDNISONE OR ITS EQUIVALENT WITHIN 6 WEEKS PRIOR TO THE BASELINE (VISIT 2).
3. HAVE RECEIVED ANY PARENTERAL (INCLUDING INTRAARTICULAR) CORTICOSTEROID INJECTION WITHIN 6 WEEKS OF BASELINE (VISIT 2).
4. CONCURRENT OR RECENT USE OF ANY BIOLOGIC DMARD (TNF-α INHIBITOR OR NOT). PATIENTS MUST HAVE STOPPED TNF-α INHIBITORS OR ANAKINRA > 28 DAYS; TOCILIZUMAB > 56 DAYS; ABATACEPT > 90 DAYS; RITUXIMAB OR ANY OTHER B CELL BIOTHERAPY > 1 YEAR, OR ANY OTHER BIOLOGICAL DMARD > 5 HALF- LIVES PRIOR TO BASELINE.
5. HAVE RECEIVED AN ORAL CALCINEURIN INHIBITOR (eg., CYCLOSPORIN OR TACROLIMUS) AT ANYTIME WITHIN 8 WEEKS OF BASELINE (VISIT 2) OR ANY PREVIOUS TREATMENT WITH ALKYLATING AGENTS SUCH AS CYCLOPHOSPHAMIDE OR CHLORAMBUCIL.
6. HAVE SUFFERED A SEVERE REACTION TO ANY BIOLOGICAL TREATMENT THAT, IN OPINION OF THE RESEARCHER, WILL MEANS AN UNACCEPTABLE RISK FOR THE PATIENT IF WILL BE PARTICIPATING IN THE STUDY.

Study & Design

• Study Type: Interventional
• Study Design: Not specified