Phase 1
Completed N=26
A Study of Japanese Rheumatoid Arthritis Participants
Source: ClinicalTrials.gov NCT01253291 ↗Enrolled (actual)
26
Serious AEs
3.9%
Results posted
Mar 2019
Primary outcomePrimary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — 0; 0; 0; 0 Participants
Summary
The objective of this study is to evaluate the safety and tolerability of 48 weeks subcutaneous (SC) dosing with LY2127399 for participants who have participated in a prior LY2127399 clinical study. At the end of the 48-week treatment period, participants will participate in a 24-week follow-up period. Additional follow up after Week 72 may continue to assess B-cell recovery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) |
0; 0; 0; 0; 0; 5 | — |
| SECONDARY Percent Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody |
19.9; 8.5; -1.2; 17.4; -4.4 | — |
| SECONDARY Percent Change From Baseline in Rheumatoid Factor (RF) |
-2.0; -9.7; -7.9; -2.3; 25.3 | — |
| SECONDARY Percent Change From Baseline in Immunoglobulins [Immunoglobulin (Ig) G, IgM, and IgA] |
-4.4; -3.8; -5.1; -5.1; -2.0; -7.7 | — |
| SECONDARY Percent Change From Baseline in CD20+ B-cell Count |
3.8; -17.3; -20.8; -32.0; -44.6 | — |
| SECONDARY Percent Change From Baseline in Peripheral B-cell Subsets |
-10.8; -14.9; -18.2; -19.6; 7.6; 12.2 | — |
| SECONDARY Percent Change From Baseline in C-Reactive Protein (CRP) |
63.0; 15.4; 19.0; -4.9; 7.1 | — |
| SECONDARY Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
-4.2; -7.8; -7.3; -4.0; -5.0 | — |
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
- Must have completed treatment and 12 week follow up period in prior LY2127399 study NCT01253226 [Study H9B-JE-BCDK (BCDK)]
Exclusion criteria
- Have had any safety event during the previous LY2127399 (BCDK) study that participants participated in
- Have received, during previous study (BCDK), any drugs prohibited in the study protocol which includes unapproved drugs, live vaccines, or any biologic or non-biologic disease-modifying anti-rheumatic drug (DMARD) except for, methotrexate (MTX), hydroxychloroquine, sulfasalazine or bucillamine
Data sourced from ClinicalTrials.gov (NCT01253291). 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.