Efficacy and safety of tregalizumab in patients with rheumatoid arthritis and an inadequate response to methotrexate: results of a phase IIb, randomised, placebo-controlled trial
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
29343509
DOI
10.1136/annrheumdis-2017-212478
PII: S0003-4967(24)00928-2
Knihovny.cz E-resources
- Keywords
- Dmards (biologic), autoimmune diseases, rheumatoid arthritis, t cells,
- MeSH
- CD4 Antigens immunology MeSH
- Antirheumatic Agents administration & dosage immunology MeSH
- Adult MeSH
- Double-Blind Method MeSH
- Antibodies, Monoclonal, Humanized administration & dosage adverse effects immunology MeSH
- Immunoglobulin G immunology MeSH
- Immunomodulation drug effects MeSH
- Injections, Subcutaneous MeSH
- Middle Aged MeSH
- Humans MeSH
- Methotrexate therapeutic use MeSH
- Adolescent MeSH
- Young Adult MeSH
- Arthritis, Rheumatoid drug therapy immunology MeSH
- Aged MeSH
- Severity of Illness Index MeSH
- Treatment Outcome MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Adolescent MeSH
- Young Adult MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase II MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- CD4 Antigens MeSH
- Antirheumatic Agents MeSH
- Antibodies, Monoclonal, Humanized MeSH
- Immunoglobulin G MeSH
- Methotrexate MeSH
- tregalizumab MeSH Browser
OBJECTIVE: To evaluate the efficacy, biological activity and safety of tregalizumab in patients with active rheumatoid arthritis (RA) and an inadequate response to methotrexate (MTX). METHODS: 321 patients were randomised (1:1:1:1) to placebo or tregalizumab 25, 100 or 200 mg once-weekly subcutaneously in addition to MTX treatment. Responders at week 12 continued the same treatment, and non-responders at week 12 were escalated to the next higher tregalizumab dose level or re-randomised from placebo to active treatment. After 24 weeks, patients could continue treatment with tregalizumab for 24 weeks (extension phase). The primary endpoint was the American College of Rheumatology 20% improvement criteria (ACR20) response rate at week 12. Safety and biological activity were monitored through week 48. RESULTS: At week 12, ACR20 response rates were not statistically significantly different between placebo and any of the tregalizumab doses. Tregalizumab injections were well tolerated; most adverse events were mild to moderate and comparable among treatment and placebo groups. Biological activity was shown by dose-dependent CD4 downmodulation. CONCLUSION: Treatment with tregalizumab did not show significant clinical efficacy in patients with active RA compared with placebo but resulted in the expected biological effect on CD4 modulation. Tregalizumab was generally well tolerated, and no new safety findings were identified. TRIAL REGISTRATION NUMBER: NCT01999192; Results.
Division of Immunology Rheumatology Stanford University School of Medicine Palo Alto California USA
Institute of Rheumatology Prague Czech Republic
Investigacion y Biomedicina de Chihuahua Chihuahua Mexico
The Rebecca MacDonald Centre For Arthritis Mount Sinai Hospital Toronto Ontario Canada
References provided by Crossref.org
ClinicalTrials.gov
NCT01999192
