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

NCT01705730 | Completed Results

• 1 other identifier: ML28269
• Study Type: observational
• Target: 71
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants on Tocilizumab Treatment at Month 6 After Treatment Initiation

  Month 6 after treatment initiation

Secondary Outcomes (34)

• Percentage of Participants With Systemic Manifestations of RA at Baseline

  Baseline

• Number of Participants With Disease-Modifying Antirheumatic Drugs (DMARDs) Intolerance and Inadequate Response

  Baseline

• Number of Participants With Inadequate Response to Other Biologics

  Baseline

• Time to Addition of Disease-Modifying Anti-rheumatic Drugs (DMARDs)

  Month 6

• Percentage of Participants Who Had DMARDs During Study

  Month 6

Study Arms (1)

Tocilizumab

Participants with rheumatoid arthritis (RA) received tocilizumab monotherapy according to individualized physician-prescribed regimens.

Drug: tocilizumab

Interventions

tocilizumab DRUG

Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.

Also known as: Actemra

Tocilizumab

Eligibility Criteria

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

Study Population

Participants with rheumatoid arthritis initiating treatment with RoActemra/Actemra in monotherapy

You may qualify if:

• Adult participants, \>/= 18 years of age
• Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
• Participants in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy in accordance with the local label and the reimbursement criteria indicating that RoActemra/Actemra can be given in monotherapy in case of methotrexate intolerance or where continued treatment with methotrexate is inappropriate; this can include participants who have received RoActemra/Actemra treatment within 8 weeks prior to the enrolment visit
• Concomitant treatment with NSAIDs and/or corticosteroids is allowed

You may not qualify if:

• Participants who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
• Participants who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
• Participants receiving concomitant DMARD treatment for rheumatoid arthritis at baseline (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) will be excluded from the study
• Participants 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
• Participants with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

ASZ Aalst

Aalst, 9300, Belgium

Location

CH EpiCURA Site Ath

Ath, 7800, Belgium

Location

CHU Brugmann (Victor Horta)

Brussels, 1020, Belgium

Location

Hospital Erasme; Neurologie

Brussels, 1070, Belgium

Location

Reumaclinic

Genk, 3600, Belgium

Location

GHdC Site Saint-Joseph

Gilly (Charleroi), 6000, Belgium

Location

Clinique Notre Dame de Grâce

Gosselies, 6041, Belgium

Location

CH Jolimont - Lobbes (Jolimont)

Haine-Saint-Paul, 7100, Belgium

Location

AZ Groeninge

Kortrijk, 8500, Belgium

Location

Chr de La Citadelle

Liège, 4000, Belgium

Location

Clinique Saint-Joseph

Liège, 4000, Belgium

Location

CHU Ambroise Paré

Mons, 7000, Belgium

Location

AZ Damiaan

Ostend, 8400, Belgium

Location

Clinique St Pierre asbl

Ottignies, 1340, Belgium

Location

AZ Delta (Campus Wilgenstraat)

Roeselare, 8800, Belgium

Location

AZ Turnhout Sint Jozef

Turnhout, 2300, Belgium

Location

Sint Augustinus Wilrijk

Wilrijk, 2610, Belgium

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

1-800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: October 10, 2012
• First Posted: October 12, 2012
• Study Start: July 31, 2012
• Primary Completion: December 12, 2014
• Study Completion: December 12, 2014
• Last Updated: September 4, 2018
• Results First Posted: September 4, 2018

Record last verified: 2018-08

Locations

BE (17)