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Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis

NCT00883896 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 195

Last updated 2022-10-21

Study results available
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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.

Conditions

Interventions

OTHER

Placebo

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

DRUG

ILV-094

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

DRUG

ILV-094

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

OTHER

Placebo

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

DRUG

ILV-094

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-18
Primary Completion
2011-02-18
Completion
2011-02-18

Countries

  • United States
  • Belgium
  • Colombia
  • Croatia
  • Germany
  • Hungary
  • Japan
  • Mexico
  • Netherlands
  • Romania
  • Russia

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00883896 on ClinicalTrials.gov