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A Study of RoActemra/Actemra (Tocilizumab) Versus Adalimumab in Combination With Methotrexate (MTX) in Patients With Moderate to Severe Active Rheumatoid Arthritis And an Inadequate Response to Treatment With Only One Tumor Necrosis Factor (TNF)-Inhibitor

NCT01283971 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2014-02-10

Study results available
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Summary

This randomized, parallel-group study will assess the efficacy and safety of RoActemra/Actemra (tocilizumab) versus adalimumab, both in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis. Patients, already treated with MTX at stable doses, will be randomized to receive either RoActemra/Actemra 8 mg/kg intravenously (IV) every 4 weeks or adalimumab 40 mg subcutaneous (SC) every 2 weeks. All patients will receive methotrexate (10-25 mg weekly) and folate (at least 5 mg weekly). The anticipated time on study treatment is 24 weeks.

Conditions

Interventions

DRUG

tocilizumab [RoActemra/Actemra]

Tocilizumab 8 mg/kg IV every 4 weeks for 24 weeks.

DRUG

adalimumab

Adalimumab 40 mg SC every 2 weeks.

DRUG

placebo to tocilizumab

Placebo to tocilizumab IV every 4 weeks for 24 weeks.

DRUG

placebo to adalimumab

Placebo to adalimumab SC every 2 weeks for 24 weeks.

DRUG

methotrexate

Methotrexate 10-25 mg weekly.

DRUG

folate

Folate at least 5 mg weekly.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States
  • Denmark
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Netherlands
  • Puerto Rico
  • Russia
  • Spain
  • Sweden

Study Locations

More Related Trials

Entities

Drugs
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 NCT01283971 on ClinicalTrials.gov