A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (MONACO)

NCT01643863 | Terminated

• 1 other identifier: ML28202
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients on RoActemra/Actemra at 6 months

  approximately 20 months

Secondary Outcomes (8)

• Rates of dose modifications/interruptions

  approximately 20 months

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

  approximately 20 months

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

  approximately 20 months

• Physician Global Assessment of disease activity

  approximately 20 months

• Patient reported outcomes: Health Assessment Questionnaires

  approximately 20 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 monotherapy, in case of methotrexate intolerance or when continuous methotrexate treatment is inadequate (in accordance with the local label), and who have received (or started) RoActemra/Actemra monotherapy treatment within 8 weeks prior to the enrolment visit.
• Concomitant corticosteroids (oral or intra-articular) or non-steroidal anti-inflammatory drugs (NSAIDs) are allowed

You may not qualify if:

• Patients in whom RoActemra/Actemra is contraindicated according to the approved Summary of Product Characteristics
• 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
• Concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting treatment with RoActemra/Actemra
• Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (3)

Unknown Facility

Lisbon, 1069-639, Portugal

Location

Unknown Facility

Lisbon, 1649-035, Portugal

Location

Unknown Facility

Porto, 4099-001, Portugal

Location

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 16, 2012
• First Posted: July 18, 2012
• Study Start: August 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

PT (3)