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
Jazyk angličtina Země Spojené státy americké Médium print-electronic
Typ dokumentu klinické zkoušky, fáze II, časopisecké články, multicentrická studie, randomizované kontrolované studie, práce podpořená grantem
PubMed
29343509
DOI
10.1136/annrheumdis-2017-212478
PII: S0003-4967(24)00928-2
Knihovny.cz E-zdroje
- Klíčová slova
- Dmards (biologic), autoimmune diseases, rheumatoid arthritis, t cells,
- MeSH
- antigeny CD4 imunologie MeSH
- antirevmatika aplikace a dávkování imunologie MeSH
- dospělí MeSH
- dvojitá slepá metoda MeSH
- humanizované monoklonální protilátky aplikace a dávkování škodlivé účinky imunologie MeSH
- imunoglobulin G imunologie MeSH
- imunomodulace účinky léků MeSH
- injekce subkutánní MeSH
- lidé středního věku MeSH
- lidé MeSH
- methotrexát terapeutické užití MeSH
- mladiství MeSH
- mladý dospělý MeSH
- revmatoidní artritida farmakoterapie imunologie MeSH
- senioři MeSH
- stupeň závažnosti nemoci MeSH
- výsledek terapie MeSH
- Check Tag
- dospělí MeSH
- lidé středního věku MeSH
- lidé MeSH
- mladiství MeSH
- mladý dospělý MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- multicentrická studie MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- Názvy látek
- antigeny CD4 MeSH
- antirevmatika MeSH
- humanizované monoklonální protilátky MeSH
- imunoglobulin G MeSH
- methotrexát MeSH
- tregalizumab MeSH Prohlížeč
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
Citace poskytuje Crossref.org
ClinicalTrials.gov
NCT01999192
