NCT00480272

Prospective Study on Intensive Early Rheumatoid Arthritis Treatment

A Phase IV Multicenter, Randomized, Double-blind Study. prospeCtive Study on Intensive Early Rheumatoid Arthritis Treatment With adalimUmab: Induction of REmission and Maintenance

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Hypothesis: Early intensive treatment with anti-TNF agent plus methotrexate plus high dose prednisone may increase remission rate and may induce stable remission in Rheumatoid Arthritis Objective: to evaluate induction of remission using adalimumab, prednisone and methotrexate and maintenance of remission after discontinuation of adalimumab and prednisone

Detailed description

Treatment group A 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + prednisone 50 mg/d tapered to 6.25 mg 6 - 12 months: Adalimumab 40 mg eow plus methotrexate 20 mg weekly group B 0 - 6 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly + placebo 6 - 12 months: Adalimumab 40 mg eow + methotrexate rapidly titrated to 20 mg weekly Follow up period - Open Label phase: Patients achieving clinical remission will be than treated only with MTX and observed for another 12 months period. Patients who do not achieve clinical remission or patients who will experience a relapse of the disease will be treated according to standard of care (SOC) modalities.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
DRUG	adalimumab, plus prednisone	adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo or prednisone 50 mg/po day then reduced to 6.25/po day
DRUG	adalimumab plus placebo	adalimumab 40 mg/sc every 2 weeks plus methotrexate 20 mg/po every week plus placebo daily for 6 months

Timeline

• Start date: 2007-05-01
• Primary completion: 2017-03-01
• Completion: 2017-03-01
• First posted: 2007-05-30
• Last updated: 2017-03-06

Locations

1 site across 1 country: Italy