Rheumatoid Arthritis
Conditions
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.
Interventions
DRUGLY2127399
Administered subcutaneously
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Synovitis Scores From Baseline up to Week 16 | 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 | 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 | Baseline up to Week 16 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Various Cell Types in the Blood From Baseline up to Week 24 | Baseline up to Week 24 | Primary and secondary analyses were not conducted given insufficient data due to termination of the trial. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LY2127399 Participants received 240 mg LY2127399 administered SC (2 SC injections of 120 mg) as a loading dose on Day 1. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Sponsor Decision | 2 |
Baseline characteristics
| Characteristic | LY2127399 |
|---|---|
| Age, Continuous | 66 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 2 Participants |
| Region of Enrollment United States | 2 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 2 | 1 / 2 |
| serious Total, serious adverse events | 1 / 2 | 1 / 2 |
Outcome results
Primary
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.
Time frame: Baseline up to Week 16
Population: No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.
Primary
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.
Time frame: Baseline up to Week 16
Population: No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.
Primary
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.
Time frame: Baseline up to Week 16
Population: No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.
Secondary
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.
Time frame: Baseline up to Week 24
Population: No participant had outcome measure data analyzed due to the termination of the trial and insufficient sample collection.