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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT01399697 |
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Date of registration:
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20/07/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate Versus RoActemra/Actemra Monotherapy in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
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Scientific title:
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A Multi-center Study of the Safety and Effect on Disease Activity of Tocilizumab (TCZ) in Combination With MTX Versus Tocilizumab Monotherapy in Patients With Rheumatoid Arthritis, With Inadequate Response to MTX (Defined as DAS 28 > 3,2) |
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Date of first enrolment:
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September 2011 |
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Target sample size:
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261 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01399697 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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Spain
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Active moderate to severe rheumatoid arthritis (DAS28 >/= 3.2) at baseline
- Currently receiving methotrexate for at least 12 weeks, at a stable oral dose of at
least 15 mg/week for at least 6 weeks prior to treatment (Day 1)
- Body weight < 150 kg
- Oral corticoids must have been at stable dose for at least 25 out of 28 days prior to
baseline; maximum dose 10 mg/day
Exclusion Criteria:
- Pregnant or nursing women
- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months after baseline
- Rheumatic autoimmune disease other than RA
- Functional class IV as defined by the American College of Rheumatology (ACR)
Classification of Functional Status in Rheumatoid Arthritis
- Prior history of or current inflammatory joint disease other than RA
- Treatment with a biologic agent at any time prior to baseline
- Treatment with traditional DMARDs other than methotrexate within 1 month (for
leflunomide 3 months) prior to baseline
- Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
- Previous treatment with RoActemra/Actemra
- History of severe allergic or anaphylactic reactions to human, humanized, or murine
monoclonal antibodies
- Known active current or history of recurrent infection
- History of or currently active primary or secondary immunodeficiency
- Active tuberculosis requiring treatment within the previous 3 years
- Positive for HIV infection
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Rheumatoid Arthritis
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Intervention(s)
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Drug: placebo
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Drug: tocilizumab [RoActemra/Actemra]
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Drug: methotrexate
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Primary Outcome(s)
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Change in Disease Activity Score Based on 28-Joint Count (DAS28) From Week 16 to Week 28
[Time Frame: Baseline, Week 16, and Week 28]
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Secondary Outcome(s)
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Change in the Quality of Life Questionnaire (SF-12) From Week 16 to Week 28 in Physical Health
[Time Frame: Week 16 and Week 28]
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Change in the Quality of Life Questionnaire (Short Form-12 [SF-12]) From Week 16 to Week 28 in Mental Health
[Time Frame: Week 16 and Week 28]
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Percentage of Participants With Simplified Disease Activity Index (SDAI) <3.3 at Week 28
[Time Frame: 28 weeks]
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Change From Week 16 to Week 28 in Global Assessment of Disease Activity as Assessed With the Visual Analogue Scale (VAS) Performed by Participant
[Time Frame: Week 16 and Week 28]
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Change in the Health Assessment Questionnaire Disability Index (HAQ-DI) From Week 16 to Week 28
[Time Frame: Week 16 and Week 28]
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Change From Week 16 to Week 28 in Global Assessment of Disease Activity Assessed Using the VAS Performed by the Investigator
[Time Frame: Week 16 and Week 28]
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Percentage of Participants With DAS28 Score Less Than (<) 2.6 at Week 28
[Time Frame: Week 28]
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Percentage of Participants With Clinical Disease Activity Index (CDAI) <2.8 at Week 28
[Time Frame: Week 28]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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