CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
New formulation adalimumabbiological
Likely dose
New formulation adalimumab 40 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01752855
NCT01752855Phase 2Completed
CompareCT.gov

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

AbbVie (prior sponsor, Abbott)·interventional·Posted Dec 19, 2012·Updated Oct 29, 2014

In Brief

A Phase 2 clinical trial evaluating New formulation adalimumab for Rheumatoid Arthritis. Completed, enrolled 88 participants across 20 sites in 7 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Czechia, Germany, Puerto Rico, Romania, Slovakia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 19, 2012
Enrollment StartDec 1, 2012
Primary CompletionOct 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.5 years ago

Interventions

New formulation adalimumabbiological

New formulation adalimumab 40 mg every other week