A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00891020
• Date of registration: 29/04/2009
• Prospective Registration: Yes
• Primary sponsor: Hoffmann-La Roche
• Public title: A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic Disease-modifying Antirheumatic Drugs (DMARDs)
• Scientific title: Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs
• Date of first enrolment: May 2009
• Target sample size: 886
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00891020
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Puerto Rico, United Kingdom, United States

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- adult patients, >=18 years of age;

- moderate to severe active rheumatoid arthritis for >6 months;

- inadequate clinical response or unable to tolerate current or prior biologic or
non-biologic Disease-modifying antirheumatic drug (DMARD) therapy;

- Swollen joint count (SJC) >/=4 and Tender joint count (TJC) >/=4

- body weight
- current permitted non-biologic DMARDs must be on stable dose for >/= 7 weeks prior to
baseline;

Exclusion Criteria:

- history of autoimmune disease or inflammatory joint disease other than rheumatoid
arthritis;

- functional class IV as defined by the American College of Rheumatology (ACR)
Classification of Functional Status in rheumatoid arthritis;

- treatment with rituximab within 6 months before screening;

- intraarticular corticosteroids within 8 weeks or intramuscular (im)/ intravenous (iv)
corticosteroids within 12 weeks prior to screening;

- known active current or history of recurrent infections, or any major episode of
infection requiring hospitalization or treatment with iv antibiotics within 4 weeks of
screening, or oral antibiotics within 2 weeks prior to screening.



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Nonbiologic DMARDs of investigator's choice

Drug: tocilizumab [RoActemra/Actemra]

Primary Outcome(s)

Percentage of Participants Experiencing at Least One Serious Adverse Event (SAE) During the 24 Week Treatment Period [Time Frame: 24 Weeks]

Secondary Outcome(s)

Number of Participants Having Their Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Weeks 12, 16, and 20 [Time Frame: Weeks 12,16, 20]

Percentage of Participants Achieving American College of Rheumatology (ACR) (ACR20/50/70) Responses at Weeks 8, 16, and 24 [Time Frame: Baseline, Weeks 8,16,24]

Change From Baseline in Routine Assessment Patient Index Data (RAPID3) Score at Weeks 8, 16, and 24 [Time Frame: Baseline, Weeks 8,16,24]

Percentage of Participants With Tocilizumab Dose Increased From 4 mg/kg to 8 mg/kg at Week 8 [Time Frame: Baseline, Week 8]

Change From Baseline in DAS28 Score at Weeks 8, 16 and 24 [Time Frame: Baseline, Weeks 8,16,24]

Percentage of Participants Achieving Clinical Remission at Weeks 8, 16, and 24 [Time Frame: Weeks 8,16,24]

Percentage of Participants Experiencing Non-serious Adverse Events of Special Interest [Time Frame: 24 Weeks]

Change From Baseline in Fatigue Visual Analogue Scale (VAS) at Weeks 8, 16, and 24 [Time Frame: Baseline, Weeks 8,16,24]

Percentage of Participants Experiencing Serious Adverse Events of Special Interest [Time Frame: 24 Weeks]

Secondary ID(s)

ML22533

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 17/04/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00891020