Phase 1
Completed N=3
TL011 in Severe, Active Rheumatoid Arthritis Patients
Source: ClinicalTrials.gov NCT01123070 ↗Enrolled (actual)
3
Serious AEs
3.7%
Results posted
Oct 2021
Primary outcomePrimary: Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B — 7571; 8377 Day*micrograms per milliliter — p=0.4265
Summary
The purpose of this study is to determine the safety and pharmacology of TL011 in patients with severe rheumatoid arthritis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Area Under the Plasma Concentration Versus Time Curve [AUC(0-t)] in Part B |
7571; 8377 | 0.4265 |
| SECONDARY Maximum Observed Concentration (Cmax) in Part B |
396; 450 | 0.0368 sig |
| SECONDARY Number of Participants With Adverse Events in Part B |
14; 16 | — |
| SECONDARY Cmax Post First Dose (C1max) and Post Second Dose (C2max) in Part B |
339; 356; 348; 448 | 0.1484 |
| SECONDARY AUC At First Dose (AUC1) and AUC At Second Dose (AUC2) in Part B |
2335; 2359; 6133; 6849 | 0.6520 |
| SECONDARY Percent Change From Baseline in CD19+ B-cell Count in Part B |
-88.9; -90.6 | — |
| SECONDARY Number of Participants With American College of Rheumatology (ACR20) Criteria Response in Part B |
14; 15 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve [AUC (0-t)] for Part A Cohort 2 |
6423 | — |
| SECONDARY Number of Participants With Adverse Events in Part A |
0; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Adult subjects
- Rheumatoid arthritis as defined by the 1987 ACR Classification
- Severe active seropositive disease
- Inadequate response or intolerance to other DMARDs
- Treatment with MTX
Exclusion Criteria
- Rheumatic autoimmune disease other than RA
- Active infection
- Known immunodeficiency syndrome
- Positive Hepatitis B surface antigen or antibodies to Hepatitis C
- History of cancer
Data sourced from ClinicalTrials.gov (NCT01123070). 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.