CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 61 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/NCT01502423
NCT01502423Phase 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 Dec 30, 2011·Updated Feb 20, 2014

In Brief

A Phase 2 clinical trial evaluating Adalimumab for Rheumatoid Arthritis. Completed, enrolled 61 participants across 7 sites in 3 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 three countries, Australia (3 sites), Canada (2 sites), and Germany (2 sites).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesAustralia, Canada, Germany
Collaborators--

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 30, 2011
Enrollment StartJan 1, 2012
Primary CompletionNov 1, 2012
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 14.5 years ago

Interventions

Adalimumabbiological

Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)