A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01670045
• Date of registration: 17/08/2012
• Prospective Registration: No
• Primary sponsor: Hoffmann-La Roche
• Public title: A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Rheumatoid Arthritis
• Scientific title: A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab
• Date of first enrolment: March 2012
• Target sample size: 43
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01670045
• Study type: Observational
• Phase: N/A

Countries of recruitment

Greece, Indonesia

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 according to the revised (1987) ACR criteria

- Patient in whom the treating physician has made the decision to commence
RoActemra/Actemra treatment in accordance with the local label (DMARD-IR, TNF-IR or
need of RoActemra/Actemra monotherapy); this can include patients who have received
RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

- Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment
visit

- Patients who have previously received RoActemra/Actemra in a clinical trial or for
compassionate use

- Patients who have received treatment with an investigational agent within 4 weeks (or
5 half-lives of the investigational agent, whichever is longer) before starting
treatment with RoActemra/Actemra

- Patients with a history of autoimmune disease or any joint inflammatory disease other
than rheumatoid arthritis



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Tocilizumab

Primary Outcome(s)

Percentage of Participants Who Remained on Tocilizumab Treatment at 6 Months After Treatment Initiation [Time Frame: Month 6]

Secondary Outcome(s)

Number of Participants Achieving a Response According to European League Against Rheumatism (EULAR) Criteria [Time Frame: Baseline up to Month 6]

Percentage of Participants With Anti-Citrullinated Cyclic Peptide (Anti-CCP) Status [Time Frame: Baseline up to Day 5]

Percentage of Participants With a Reduction of at Least 2.6 Units in DAS28 From Baseline [Time Frame: Baseline, Month 1, 2, 3, 4, 5, 6]

Percentage of Participants With Tocilizumab Dose Modifications [Time Frame: Baseline up to Month 6]

Percentage of Participants With Rheumatoid Factor Status [Time Frame: Baseline up to Day 5]

Percentage of Participants With Different Body Mass Index (BMI) [Time Frame: Baseline up to Day 5]

Number of Participants With Different Types of Clinical Disease Activity Index (CDAI) [Time Frame: Baseline up to Month 6]

Change From Baseline in Physician Global Assessment of Disease Activity at Months 3 and 6 [Time Frame: Baseline, Months 3, 6]

Number of Participants With Different Types of Simplified Disease Activity Index (SDAI) [Time Frame: Baseline up to Month 6]

Percentage of Participants Achieving a Response According to ACR Criteria [Time Frame: Month 1, 2, 3, 4, 5, 6]

Percentage of Participants With RA Diagnosis [Time Frame: Baseline up to Day 5]

Number of Participants With Reduction/Withdrawal of Disease-modifying Anti-rheumatic Drugs (DMARDs) and/or Corticosteroids [Time Frame: Baseline, up to Month 6]

Secondary ID(s)

ML28216

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 10/05/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01670045