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Study Evaluating Multiple Doses Of ATN-103 In Subjects With Active Rheumatoid Arthritis

NCT00959036 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2013-01-30

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of ATN-103 when administered to subjects with active rheumatoid arthritis compared with placebo. All subjects must be on a stable dose and route of methotrexate.

Conditions

  • Active Rheumatoid Arthritis

Interventions

DRUG

ATN-103

10 mg every 4 weeks until week 12

DRUG

ATN-103

10 mg every 8 weeks until week 12

DRUG

ATN-103

30 mg every 4 weeks until week 12

DRUG

ATN-103

80 mg every 4 weeks until week 12

DRUG

ATN-103

80 mg every 8 weeks until week 12

DRUG

Placebo

Placebo every 4 weeks

DRUG

Methotrexate

Sponsors & Collaborators

  • Ablynx, a Sanofi company

    lead INDUSTRY

Principal Investigators

  • Josefin-Beate Holz, MD · Ablynx, a Sanofi company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-01-31
Completion
2011-01-31

Countries

  • United States
  • Belgium
  • Canada
  • Germany
  • Hungary
  • Russia
  • Serbia
  • South Africa
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs

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 NCT00959036 on ClinicalTrials.gov