An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01254331
• Date of registration: 03/12/2010
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: An Open-label Study With Tocilizumab in Patients With Rheumatoid Arthritis in a Local Environment
• Scientific title: Open Label, Multicenter, Trial to Evaluate Safety, Tolerability and Efficacy of Tocilizumab in Monotherapy or in Combination With MTX in Patients With Active Rheumatoid Arthritis Who Have an Inadequate Response to Current Non Biologic DMARDs
• Date of first enrolment: February 2011
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01254331
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Tunisia

Contacts

• Name: Clinical Trials
• Affiliation: Hoffmann-La Roche

Key inclusion & exclusion criteria

Inclusion Criteria:

- Adult patients >/=18 years of age

- Moderate to severe rheumatoid arthritis defined as DAS 28>3.2

- Body weight
- Patient on at least 1 non-biologic DMARD on a stable dose for at least 8 weeks at any
time prior to study start

- Inadequate clinical response to a stable dose of a non-biologic DMARD

Exclusion Criteria:

- Major surgery within 8 weeks prior to screening or planned major surgery within 6
months following enrollment

- Rheumatic autoimmune disease other than rheumatoid arthritis (RA)

- Functional class IV as defined by the ACR classification

- History or current inflammatory joint disease other than RA

- Previous treatment with any cell depleting therapy

- Previous treatment with methotrexate

- Previous treatment with tocilizumab

- Previous treatment with any biologic drug that is used in the treatment of RA



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: tocilizumab [RoActemra]

Primary Outcome(s)

Percentage of Participants With Adverse Events (AEs), Serious AEs (SAEs), Related AEs, Discontinuation Due to AEs, or Death [Time Frame: Baseline, every 4 weeks through Week 52]

Secondary Outcome(s)

Assessment of Physical Function Using Health Assessment Questionnaire (HAQ) [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Assessment of Global Disease by the Participant Using VAS [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Number of Participants Who Discontinued Tocilizumab [Time Frame: Week 52]

Percentage of Participants Achieving Remission Assessed Using DAS28 [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Percentage of Participants Who Achieved Clinically Significant Improvement Assessed Using Disease Activity Score Based on 28 Joints (DAS28) [Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Percentage of Participants Experiencing Fatigue [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, and 24]

Percentage of Participants Achieving LDA Assessed Using DAS28 [Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Percentage of Participants With American College of Rheumatology (ACR) 20 Percent (%), 50% or 70% Improvement (ACR20/ACR50/ACR70) [Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Mean C-Reactive Protein (CRP) Levels [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

SJC and TJC [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Time To Achieve ACR20/ACR50/ACR70 [Time Frame: Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Assessment of Pain by the Participant Using Visual Analog Scale (VAS) [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Mean Erythrocyte Sedimentation Rate (ESR) Levels [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Assessment of Global Disease by the Physician Using Visual Analog Scale (VAS) [Time Frame: Baseline and Weeks 4, 8, 12, 16, 20, 24, 36, 48 and 52]

Secondary ID(s)

ML22642

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/02/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01254331