CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
Adalimumabbiological
Likely dose
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/NCT01561313
NCT01561313Phase 2Completed
CompareCT.gov

A Multicenter, Randomized, Single-Blind Crossover Study of the Safety and Tolerability of Two Adalimumab Formulations in Adult Subjects With Rheumatoid Arthritis.

AbbVie (prior sponsor, Abbott)·interventional·Posted Mar 23, 2012·Updated Feb 20, 2014

In Brief

A Phase 2 clinical trial evaluating Adalimumab for Rheumatoid Arthritis. Completed, enrolled 64 participants across 6 sites in 2 countries.

Detailed Summary

This study will compare injection site pain levels between current Humira® formulation versus a new formulation of Humira in patients with Rheumatoid Arthritis (RA), who are either currently on a stable dose (minimum six consecutive doses) of on-label Humira or biological naïve who will be prescribed on-label Humira as treatment for their Rheumatoid Arthritis. The study is being conducted in two countries, Belgium (3 sites) and the Czech Republic (3 sites).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Czechia
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 23, 2012
Enrollment StartMar 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.3 years ago

Interventions

Adalimumabbiological

Subcutaneously 40 mg every other week (EOW) or every week (EW) (as dosing requires)