Phase 2
Completed N=182
An Open Label Extension Study in Participants With Rheumatoid Arthritis
Source: ClinicalTrials.gov NCT00837811 ↗Enrolled (actual)
182
Serious AEs
8.2%
Results posted
Apr 2018
Primary outcomePrimary: Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 38; 95; 1; 4 Participants
Summary
To evaluate the safety and tolerability of LY2127399 administered as subcutaneous injections for 48 weeks in participants with Rheumatoid Arthritis
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Had Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
38; 95; 1; 4; 16; 1 | — |
| PRIMARY Number of Participants With Planned Laboratory Evaluations (Including Hematology, Clinical Chemistry, and Urinalysis) Reported as AEs |
0; 1; 0; 0; 1; 0 | — |
| SECONDARY Change From Baseline in Tender Joint Count [Individual Component of the American College of Rheumatology (ACR) Core Set] |
-9.2; -6.5; -12.0 | — |
| SECONDARY Change From Baseline in Swollen Joint Count (Individual Component of the ACR Core Set) |
-7.6; -5.3; 2.0 | — |
| SECONDARY Change From Baseline in Participant's Assessment of Disease Activity (Individual Component of the ACR Core Set) |
-26.1; -16.7; -68.0 | — |
| SECONDARY Change From Baseline in Physician's Global Assessment of Disease Activity (Individual Component of the ACR Core Set) |
-29.1; -18.4; -38.0 | — |
| SECONDARY Change From Baseline in Health Assessment Questionnaire-Disability Index [(HAQ-DI) Individual Component of the ACR Core Set] |
-0.3; -0.3; -0.5 | — |
| SECONDARY Change From Baseline in Participant's Assessment of Joint Pain (Individual Component of the ACR Core Set) |
-26.9; -13.4; -68.0 | — |
| SECONDARY Percent Change From Baseline in C-Reactive Protein [(CRP) Individual Component of the ACR Core Set] |
-11.1; 50.7; 241.4 | — |
| SECONDARY Percentage of Participants Achieving ACR20 Response |
66.1; 32.5; 0.0 | — |
| SECONDARY Percentage of Participants ACR50 Response |
33.9; 13.3; 0.0 | — |
| SECONDARY Percentage of Participants Achieving ACR70 Response |
18.6; 6.7; 0.0 | — |
| SECONDARY ACR-N Response |
31.9; 11.3 | — |
| SECONDARY Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue Score |
5.2; 5.1; -6.0 | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28 Joint Count (DAS28) |
-2.0; -1.3; -1.3 | — |
| SECONDARY Percentage of Participants With Response Based on European League Against Rheumatism Responder Index, 28 Joint Count (EULAR28) |
16.1; 44.4; 0; 48.2; 39.3; 100.0 | — |
| SECONDARY Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) Component Scores |
5.7; 4.1; 1.4; 4.7; 2.9; -2.9 | — |
| SECONDARY Pharmacodynamics: Change From Baseline in Total B Cells [Cluster Designation 20+ (CD20+)] Absolute Cell Counts |
-113.1; -110.3; -135.9; -143.1; -141.0; -151.6 | — |
| SECONDARY Pharmacodynamics: Change From Baseline in Peripheral Blood B Cell Subsets (Absolute Cell Counts) |
-115.0; -109.2; -138.8; -95.9; -102.6; -189.0 | — |
| SECONDARY Pharmacodynamics: Change From Baseline in Serum Immunoglobulin |
-1.8; -2.0; -1.9; -0.3; -0.3; -0.2 | — |
| SECONDARY Pharmacodynamics: Change From Baseline in Rheumatoid Factor (RF) Levels at Week 52 |
-26.9; -53.8 | — |
| SECONDARY Pharmacodynamics: Change From Baseline in Serum Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibodies |
6.9; -19.4; 0.0 | — |
| SECONDARY Pharmacodynamics: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
5.0; 20.9; -25.0 | — |
| SECONDARY Number of Participants With LY2127399 Immunogenicity (Anti-LY2127399 Antibodies) |
2; 1; 0; 6; 15; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Have given written informed consent
- Women must not be pregnant, breastfeeding or be at risk to become pregnant during study participation
- Have participated in either Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928)
Exclusion Criteria
- Have had, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any safety event, [including having a recent, ongoing, or serious infection, a serious drug reaction, or any adverse event (AE) that caused discontinuation from treatment] that in the opinion of the investigator poses an unacceptable risk to participation in the study.
- Have received, during Study H9B-MC-BCDG (NCT00689728) or Study H9B-MC-BCDH (NCT00785928), any drug not allowed by the study protocol including unapproved drugs, biologic disease-modifying anti-rheumatic drugs (DMARDs), or live vaccines.
- Enrollment in any other clinical trial involving off-label use of an investigational drug or device, or enrollment in any other type of medical research.
Data sourced from ClinicalTrials.gov (NCT00837811). 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. Informational only — not medical advice.