drugset / Trial / NCT01853033
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Multiple Subcutaneous Injections of ABT-122 in Subjects With Rheumatoid Arthritis
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ABT-122 in subjects with Rheumatoid Arthritis.
Timeline
- Start
- 2013-07
- Primary completion
- 2014-05
- Completion
- 2014-05
Publications
- Results Khatri A, Goss S, Jiang P, Mansikka H, Othman AA. Pharmacokinetics of ABT-122, a TNF-alpha- and IL-17A-Targeted Dual-Variable Domain Immunoglobulin, in Healthy Subjects and Patients with Rheumatoid Arthritis: Results from Three Phase I Trials. Clin Pharmacokinet. 2018 May;57(5):613-623. doi: 10.1007/s40262-017-0580-y.
- Fleischmann RM, Wagner F, Kivitz AJ, Mansikka HT, Khan N, Othman AA, Khatri A, Hong F, Jiang P, Ruzek M, Padley RJ. Safety, Tolerability, and Pharmacodynamics of ABT-122, a Tumor Necrosis Factor- and Interleukin-17-Targeted Dual Variable Domain Immunoglobulin, in Patients With Rheumatoid Arthritis. Arthritis Rheumatol. 2017 Dec;69(12):2283-2291. doi: 10.1002/art.40319. Epub 2017 Nov 8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | REMTOLUMAB | Protein / enzyme biologic | 0.5 mg/kg | Subcutaneous |
| Subject | REMTOLUMAB | Protein / enzyme biologic | 1.5 mg/kg | Subcutaneous |
| Subject | REMTOLUMAB | Protein / enzyme biologic | 3 mg/kg | Subcutaneous |