CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 65 enrolled
Drug / intervention
abatacept +1 morebiological
Likely dose
abatacept 500 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/NCT01116427
NCT01116427Phase 2Completed

A Phase II, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Abatacept in Adults With Relapsing-remitting Multiple Sclerosis

National Institute of Allergy and Infectious Diseases (NIAID)·interventional·Posted May 5, 2010·Updated Sep 15, 2016

In Brief

A Phase 2 clinical trial evaluating abatacept and Placebo for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 65 participants across 21 sites in 2 countries.

Detailed Summary

The ACCLAIM study is testing whether the medication "abatacept" can be of benefit to patients with relapsing-remitting multiple sclerosis (MS). Although abatacept is an investigational medication for MS, it is not a new drug. Abatacept has been approved by the FDA to treat rheumatoid arthritis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, United States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 5, 2010
Enrollment StartSep 1, 2010
Primary CompletionJun 1, 2014
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.2 years ago

Interventions

abataceptbiological

In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52; Dosing: less than 60 kg, 500 mg; 60-100 kg, 750 mg; or greater than 100 kg, 1 gram

Placebodrug

In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52