Phase 1
Completed N=32
A Study for Japanese Participants With Rheumatoid Arthritis (RA)
Source: ClinicalTrials.gov NCT01253226 ↗Enrolled (actual)
32
Serious AEs
12.5%
Results posted
Oct 2018
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) [Clinically Significant Effects] — 0; 1; 1; 1 Participants
Summary
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period. All participants will be followed for up to 12 weeks after the last study drug administration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) [Clinically Significant Effects] |
0; 1; 1; 1; 1; 5 | — |
| SECONDARY Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC) |
57.0; 148; 303; 303; 30.3; 86.5 | — |
| SECONDARY PK of Tabalumab: Maximum Observed Drug Concentration (Cmax) |
2.88; 7.61; 16.6; 25.0 | — |
| SECONDARY Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts |
13.7; 15.6; 16.1; 13.7; 34.9; 42.8 | — |
| SECONDARY Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method] |
-63.3; 63.3; 9.3 | — |
| SECONDARY Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method) |
NA; NA | — |
| SECONDARY Change From Baseline in Rheumatoid Factor (RF) |
-38.6; 29.6; -108.0; -41.5; -12.9 | — |
| SECONDARY Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA) |
-0.1; 0.0; 0.5; -0.6; -0.1; -2.2 | — |
| SECONDARY Percent Change From Baseline in CRP |
210.8; -16.0; -8.5; 16.8; 42.9; -54.0 | — |
| SECONDARY Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
-5.9; -22.0; -7.5; 11.7; 6.1; -27.5 | — |
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
- Diagnosis of RA
- Active RA
- Current, regular use of Methotrexate, at a stable dose
- Body weight between 40 and 105 kilograms (kg), inclusive
Exclusion Criteria
- Use of excluded medications (reviewed by study doctor)
- Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
- Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation
- Evidence of tuberculosis
- Have systemic inflammatory condition other than RA
Data sourced from ClinicalTrials.gov (NCT01253226). 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.