A Study of LY2127399 in Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01576549
First received: April 10, 2012
Last updated: September 27, 2013
Last verified: September 2013
  Purpose

This study will investigate how LY2127399 works in participants with rheumatoid arthritis (RA) who are not adequately responding to methotrexate. Participants will receive LY2127399 via an injection(s) under the skin at 4 week intervals for up to 52 weeks. Key study procedures include biopsies of the lining of an inflamed joint and blood tests to measure RA activity.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: LY2127399
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial Biopsies

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Percent change in synovitis scores from baseline up to week 16 [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Percent change in synovial B cell mass from baseline up to week 16 [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]
  • Percent change in synovial immunoglobulin (Ig) synthesis from baseline up to week 16 [ Time Frame: Baseline up to Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percent change in various cell types in the blood from baseline up to week 24 [ Time Frame: Baseline up to Week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: May 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LY2127399
LY2127399 given subcutaneously (SC) at 240 mg for a loading dose in the first week followed by 120 mg SC every 4 weeks for up to 52 weeks.
Drug: LY2127399
Administered subcutaneously (SC)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of adult onset RA disease according to revised 1987 American Rheumatism Association (ARA) criteria who are currently or have a documented history of positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) and who have moderately to severely active RA despite ongoing methotrexate (MTX) therapy
  • Have active RA defined as the presence of at least 8/68 tender and at least 8/66 swollen joints, as determined by the tender joint count and swollen joint count assessment forms
  • Have a screening C-reactive protein (CRP) measurement greater than 1.2 times upper limit of normal or erythrocyte sedimentation rate (ESR) greater than 28 mm/hr
  • Have a clinically inflamed joint suitable for synovial biopsy procedure

Exclusion Criteria:

  • Have used an unstable dose of non-steroidal anti-inflammatory drugs (NSAIDs) within 6 weeks prior to baseline
  • Have used oral corticosteroids at average daily doses of >10 mg/day of prednisone or its equivalent within 6 weeks prior to baseline
  • Have received any parenteral corticosteroid injection within 6 weeks of baseline
  • Have used other disease-modifying anti-rheumatic drugs (DMARDs) other than MTX, hydroxychloroquine and/or sulfasalazine in the 8 weeks prior to baseline
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01576549

Locations
United States, Maryland
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Frederick, Maryland, United States, 21702
United States, Michigan
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Battle Creek, Michigan, United States, 49015
United States, Ohio
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mayfield Village, Ohio, United States, 44143
United States, Texas
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mesquite, Texas, United States, 75150
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

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01576549     History of Changes
Other Study ID Numbers: 14319, H9B-MC-BCEE
Study First Received: April 10, 2012
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014