CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 195 enrolled
Drug / intervention
ILV-094 +4 moredrug
Likely dose
ILV-094 100 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/NCT00883896
NCT00883896Phase 2Completed
CompareCT.gov

RANDOMIZED, PARALLEL, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ILV-094 ADMINISTERED SUBCUTANEOUSLY TO SUBJECT WITH RHEUMATOID ARTHRITIS.

Pfizer·interventional·Posted Apr 20, 2009·Updated Oct 21, 2022

In Brief

A Phase 2 clinical trial evaluating Placebo and ILV-094 for Rheumatoid Arthritis. Completed, enrolled 195 participants across 52 sites in 11 countries.

Detailed Summary

The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRheumatoid Arthritis
CountriesBelgium, Colombia, Croatia, Germany, Hungary, Japan, Mexico, Netherlands, Romania, Russia, United States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 20, 2009
Enrollment StartJun 18, 2009
Primary CompletionFeb 18, 2011
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 17.2 years ago

Interventions

Placeboother

Part 1: Placebo SC administration every 2 weeks X 10 weeks.

ILV-094drug

Part 1: ILV-094 100 mg SC every 4 weeks (alternating ILV-094 100 mg and placebo every 2 weeks) X 10 weeks.

ILV-094drug

Part 1: ILV-094 100 mg SC every 2 weeks X 10 weeks.

Placeboother

Part 2: Placebo SC administration every 2 weeks X 10 weeks

ILV-094drug

Part 2: ILV-094 200 mg SC every 2 weeks X 10 weeks