A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs
NCT ID: NCT01878318
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE4
INTERVENTIONAL
2013-06-30
2015-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
RoActemra/Actemra
methotrexate
stable dose
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks, 24 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
methotrexate
stable dose
tocilizumab [RoActemra/Actemra]
8 mg/kg intravenously every 4 weeks, 24 weeks
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of \>/= 6 months duration
* Active moderate to severe rheumatoid arthritis (DAS \>/= 3.2)
* Swollen joint count (SJC) \>/= 6, tender joint count \>/= 8
* Synovitis in the dominant hand
* Inadequate response to stable dose of a non-biological DMARD for at least 3 months
* Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
* Patient on outpatient treatment
Exclusion Criteria
* Rheumatic autoimmune disease other than rheumatoid arthritis
* American College of Rheumatology (ACR) functional class IV
* History of or current inflammatory joint disease other than rheumatoid arthritis
* Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
* Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
* Inadequate hematologic, renal or liver function
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or lactating women
* History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
* Current infections or history of recurrent infections
* History of or currently active primary or acquired immunodeficiency
* Active tuberculosis requiring treatment in the previous 3 years
* Body weight \> 150 kg
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ML28204
Identifier Type: -
Identifier Source: org_study_id