Phase 3
N=1,004
A Rheumatoid Arthritis Study in Participants
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01202760 ↗Enrolled (actual)
1,004
Serious AEs
3.3%
Results posted
Apr 2018
Primary outcome: Primary: Percentage of Participants With American College of Rheumatology 20% (ACR20) Response — 34.4; 33.5; 31.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- LY2127399 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With American College of Rheumatology 20% (ACR20) Response |
34.4; 33.5; 31.5 | — |
| SECONDARY Percentage of Participants With American College of Rheumatology 50% (ACR50) and 70% (ACR70) Responses |
11.6; 11.7; 12.7; 4.7; 6.3; 4.7 | — |
| SECONDARY Mean Percent Improvement in American College of Rheumatology Percent Improvement (ACR-N) |
-11.5; -9.5; -11.5 | — |
| SECONDARY Change From Baseline to 24 Weeks in Tender Joint Count (68 Joint Count) |
-1.61; -1.63; -2.11 | — |
| SECONDARY Change From Baseline to 24 Weeks in Swollen Joint Count (66 Joint Count) |
-2.59; -3.18; -3.59 | — |
| SECONDARY Change From Baseline to 24 Weeks in Participant's Assessment of Pain (Visual Analog Scale) |
-9.0; -9.6; -6.9 | — |
| SECONDARY Change From Baseline to 24 Weeks in Participant's Global Assessment of Disease Activity (Visual Analog Scale) |
-10.2; -10.2; -6.9 | — |
| SECONDARY Change From Baseline to 24 Weeks in Physician's Global Assessment of Disease Activity (Visual Analog Scale) |
-10.0; -12.4; -9.7 | — |
| SECONDARY Change From Baseline to 24 Weeks in Disease Activity Score (Based on 28 Joint Count)-C-Reactive Protein (DAS28-CRP) |
-0.42; -0.49; -0.41 | — |
| SECONDARY Change From Baseline to 24 Weeks in Health Assessment Questionnaire-Disability Index (HAQ-DI) |
-0.21; -0.18; -0.15 | — |
| SECONDARY Time to American College of Rheumatology 20% (ACR20) Response |
16.7; 16.1; 16.4 | — |
| SECONDARY Probability of an ACR20 Response by 24 Weeks |
0.612; 0.611; 0.608 | — |
| SECONDARY Percentage of Participants With DAS28-Based European League Against Rheumatism (EULAR) Response |
50.3; 49.7; 46.4 | — |
| SECONDARY Change From Baseline to 24 Weeks in Medical Outcomes Study 36-Item Short Form (SF-36) Health Status Survey Domain and Summary Scores |
2.07; 3.14; 1.48; 1.62; 2.08; 1.34 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) up to Week 24 Endpoint |
2.69; 1.92; 1.76 | — |
| SECONDARY Change From Baseline to 24 Weeks in Absolute CD3-CD20+ B-cell Counts |
-50.5; -74.4; -0.7 | — |
| SECONDARY Change From Baseline to 24 Weeks in Serum Immunoglobulin (Ig) Levels |
-0.813; -0.758; 0.117; -0.209; -0.224; 0.139 | — |
| SECONDARY Population Pharmacokinetics (PK) |
3.60 | — |
| SECONDARY Percentage of Participants Developing Anti-LY2127399 Antibodies |
2.4; 1.9; 2.8 | — |
Summary
The primary purpose of this study is to help answer if LY2127399 is safe and effective in the treatment of rheumatoid arthritis with or without background disease-modifying anti-rheumatic drug (DMARD) therapy.
This study is comprised of 2 periods:
Period 1 - 24-week blinded treatment
Period 2 - 48-week post-treatment follow-up
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Rheumatoid Arthritis (RA) of more than 6 months and less than 15 years
- Global Assessment of Disease Activity visual analog scale (VAS) greater than or equal to 20/100 millimeters (mm)
- If on one or more conventional disease-modifying anti-rheumatic Drugs (DMARDs) at randomization, must have been on a stable dose for at least 8 weeks prior to study start.
- Women must not be pregnant, breastfeeding, or become pregnant during the study
Exclusion Criteria
- Use of unstable doses of non-steroidal inflammatory drugs (NSAIDS) in the past 6 weeks
- Steroid injection or intravenous (IV) infusion in the last 6 weeks
- Use of more than 10 milligrams per day (mg/day) of oral steroids in the last 6 weeks
- Use of biologic DMARD concurrently or recently
- History of a serious reaction to other biological DMARDs
- Use of an oral calcineurin inhibitor (for example, cyclosporin or tacrolimus) in the last 8 weeks
- Surgery on a joint or other major surgery less than 2 months prior to study start, or plans to have joint surgery or major surgery during the study
- Active fibromyalgia, juvenile chronic arthritis, spondyloarthropathy, Crohn's disease, ulcerative colitis, psoriatic arthritis, or other systemic inflammatory condition except RA
- Cervical cancer or squamous skin cancer within the past 3 years, or other cancer within the past 5 years
- Received a live vaccine within the past 12 weeks (for example, vaccines for measles, mumps, rubella, and chicken pox, and nasal-spray flu vaccines)
- Hepatitis or human immunodeficiency virus (HIV)
- A serious bacterial infection (for example, pneumonia or cellulitis) within 3 months or a serious bone or joint infection within 6 months
- Symptoms of herpes zoster or herpes simplex within the last month
- Active or latent tuberculosis (TB)
- Current symptoms of a serious disorder or illness
- Use of an investigational drug within the last month
Data sourced from ClinicalTrials.gov (NCT01202760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.