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A Study of LY2127399 in Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
LY2127399
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of adult onset RA disease according to revised 1987 American Rheumatism Association (ARA) criteria and currently have a documented history of positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) and 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 millimeters/hour (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 milligrams/day (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

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LY2127399

Arm Description

LY2127399 given subcutaneously (SC) at 240 milligrams (mg) as a loading dose in the first week followed by 120 mg SC every 4 weeks for up to 52 weeks.

Outcomes

Primary Outcome Measures

Percent Change in Synovitis Scores From Baseline up to Week 16
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Percent Change in Synovial B Cell Mass From Baseline up to Week 16
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.

Secondary Outcome Measures

Percent Change in Various Cell Types in the Blood From Baseline up to Week 24
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.

Full Information

First Posted
April 10, 2012
Last Updated
March 24, 2018
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01576549
Brief Title
A Study of LY2127399 in Rheumatoid Arthritis
Official Title
An Exploratory Open-Label Biomarker Study of LY2127399 in Patients With Moderate to Severe Rheumatoid Arthritis Receiving Synovial Biopsies
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Terminated
Why Stopped
Insufficient efficacy observed in study BCDM(NCT01198002) and BCDV(NCT01202773).
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY2127399
Arm Type
Experimental
Arm Description
LY2127399 given subcutaneously (SC) at 240 milligrams (mg) as a loading dose in the first week followed by 120 mg SC every 4 weeks for up to 52 weeks.
Intervention Type
Drug
Intervention Name(s)
LY2127399
Other Intervention Name(s)
tabalumab
Intervention Description
Administered subcutaneously
Primary Outcome Measure Information:
Title
Percent Change in Synovitis Scores From Baseline up to Week 16
Description
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Time Frame
Baseline up to Week 16
Title
Percent Change in Synovial B Cell Mass From Baseline up to Week 16
Description
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Time Frame
Baseline up to Week 16
Title
Percent Change in Synovial Immunoglobulin (Ig) Synthesis From Baseline up to Week 16
Description
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Time Frame
Baseline up to Week 16
Secondary Outcome Measure Information:
Title
Percent Change in Various Cell Types in the Blood From Baseline up to Week 24
Description
Primary and secondary analyses were not conducted given insufficient data due to termination of the trial.
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of adult onset RA disease according to revised 1987 American Rheumatism Association (ARA) criteria and currently have a documented history of positive for rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibody (anti-CCP Ab) and 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 millimeters/hour (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 milligrams/day (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21702
Country
United States
Facility Name
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.
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49015
Country
United States
Facility Name
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.
City
Mayfield
State/Province
Ohio
ZIP/Postal Code
44143
Country
United States
Facility Name
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.
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States

12. IPD Sharing Statement

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A Study of LY2127399 in Rheumatoid Arthritis

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