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TERMINATEDPHASE4

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

A Randomized, Open-label, Parallel-group Study of the Reduction of Signs and Symptoms During Treatment With Tocilizumab Versus Adalimumab, Both in Combination With MTX, in Patients With Moderate to Severe Active Rheumatoid Arthritis and an Inadequate Response to Treatment With Only One TNF Inhibitor

NCT01283971•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Adult patients, \>/= 18 years of age
•Rheumatoid arthritis of \>/= 6 months duration (according to American College of Rheumatology (ACR) criteria)(according to ACR criteria)
•Inadequate response due to inefficacy of treatment (for at least 3 months) with only one approved Tumor Necrosis Factor (TNF)-agent other than adalimumab Depending on the TNF-inhibitor, last dose of TNF-inhibitor should have been 1 to 8 weeks before randomization to the study
•On methotrexate treatment for \>/=12 weeks immediately prior to baseline, with stable dose (10-25 mg/week) for the last 8 weeks
•Disease Activity Score (DAS28) \>3.2 at baseline
•Oral corticosteroids (\</=10 mg/day prednisone or equivalent) and non-steroidal anti-inflammatory drugs (NSAIDs) are permitted if the dose has been stable for \>/=6 weeks prior to baseline.

Exclusion Criteria

•Major surgery (including joint surgery) within 8 weeks prior to screening or planned surgery within 6 months following randomization
•Rheumatic autoimmune disease other than rheumatoid arthritis
•Prior history of or current inflammatory joint disease other than rheumatoid arthritis
•Functional class IV (ACR criteria)
•History of severe allergic reaction to human, humanized or murine monoclonal antibodies
•Known active current or history of recurrent infection (including tuberculosis)
•Primary or secondary immunodeficiency (history of or currently active)
•Body weight \>150 kg
•Previous treatment with any cell-depleting therapies
•Previous treatment with tocilizumab
+1 more criteria

Locations (170)

Huntsville, Alabama, United States

Phoenix, Arizona, United States

Tucson, Arizona, United States

Covina, California, United States

Escondido, California, United States

Huntington Beach, California, United States

La Mesa, California, United States

Lakewood, California, United States

Long Beach, California, United States

Los Angeles, California, United States

Key Dates

Start Date

May 1, 2011

Primary Completion Date

August 1, 2012

Completion Date

August 1, 2012

Last Updated

February 10, 2014

Enrollment

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

tocilizumab [RoActemra/Actemra]

DRUG

adalimumab

DRUG

placebo to tocilizumab

DRUG

placebo to adalimumab

DRUG

methotrexate

DRUG

folate

DRUG

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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RECRUITING

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

NCT07484243

Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Plant-Based Diet for Patients With Rheumatoid Arthritis

A Phase II Trial of SHR-3045 Injection in Patients With Rheumatoid Arthritis

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis