A Non-Interventional Study in Patients With Rheumatoid Arthritis Who Are Treated With RoActemra/Actemra (Tocilizumab)

NCT01893255 | Withdrawn

• 1 other identifier: ML28443
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This observational study will evaluate the use and efficacy of RoActemra/Actemra (tocilizumab) in monotherapy in routine clinical practice in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the approved label will be followed for 6 months.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients on RoActemra/Actemra at 6 months after treatment initiation

  Month 6

Secondary Outcomes (6)

• Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment

  approximately 6 months

• Rates of dose modifications/interruptions

  approximately 6 months

• Efficacy: Response according to total joint count evaluation by DAS28/EULAR/SDAI/CDAI/ACR

  approximately 6 months

• Physician's Global Assessment of Disease Activity

  approximately 6 months

• Safety: Incidence of adverse events

  approximately 6 months

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with rheumatoid arthritis initiated on treatment with RoActemra/Actemra in monotherapy

You may qualify if:

• Adult patients, \>/= 18 years of age
• Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
• Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in accordance with the local label; this can include patients who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
• Patients who for any reason do not take methotrexate and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
• Patients who were previously on a TNF inhibitor as monotherapy, and the treating physician has made a decision to prescribe RoActemra/Actemra as monotherapy
• Concomitant treatment with corticosteroids (orally and intra-articularly) and/or NSAIDs is allowed

You may not qualify if:

• 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 receiving concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine)
• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2013
• First Posted: July 8, 2013
• Study Start: September 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11