NCT01752855

Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

A Phase 2b, Multicenter, Open-Label Study in Rheumatoid Arthritis Subjects Who Completed Preceding Study M13-390 With Adalimumab

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: AbbVie (prior sponsor, Abbott) · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

Detailed description

All participants who completed Study NCT01712178 had an opportunity to enroll into the study and to receive the new adalimumab formulation at a dose of 40 mg every other week (eow) for an additional 24 weeks.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	New formulation adalimumab	New formulation adalimumab 40 mg every other week

Timeline

• Start date: 2012-12-01
• Primary completion: 2013-10-01
• Completion: 2013-10-01
• First posted: 2012-12-19
• Last updated: 2014-10-29
• Results posted: 2014-10-29

Locations

20 sites across 7 countries: United States, Belgium, Czechia, Germany, Puerto Rico, Romania, Slovakia