An Observational Study of Tocilizumab (Actemra) in Participants With Moderate to Severe Rheumatoid Arthritis

NCT01741688 | Completed Results

• 1 other identifier: ML28206
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 4

Brief Summary

This observational study evaluates the use and efficacy of intravenous (IV) tocilizumab in routine clinical practice in participants with moderate to severe rheumatoid arthritis. Eligible participants initiated on tocilizumab treatment in accordance with the local label were followed for 6 months.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants on Tocilizumab at 6 Months After Treatment Initiation

  At 6 months

Secondary Outcomes (15)

• Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis

  At baseline

• Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure

  At baseline

• Number of Participants Starting Tocilizumab After Failing Other Biologic Agents

  At baseline

• Median Dose at 6 Months

  At 6 months

• Number of Participants With Dose Modifications at 6 Months

  At 6 months

Study Arms (1)

Tocilizumab

Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).

Biological: Tocilizumab

Interventions

Tocilizumab BIOLOGICAL

Tocilizumab was administered according to the local label.

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 (RA) initiated on treatment with tocilizumab

You may qualify if:

• Adults, \>/= 18 years of age
• Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria
• Participants in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include participants who have received tocilizumab treatment within 8 weeks prior to the enrollment visit

You may not qualify if:

• Participants who have received tocilizumab more than 8 weeks prior to the enrollment visit
• Participants who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with tocilizumab
• History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (4)

ABK Reuma SRL- Medicentro BioCiencias

Lima, Lima 21, Peru

Location

Hospital de la Mujer

Lima, Lima 34, Peru

Location

Clinica San Borja; Servicio De Reumatologia

Lima, Lima 41, Peru

Location

Clinica El Golf

San Isidro, L27 Lima, Peru

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-LaRoche

genentech@druginfo.com

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: November 30, 2012
• First Posted: December 5, 2012
• Study Start: October 26, 2012
• Primary Completion: March 6, 2014
• Study Completion: March 6, 2014
• Last Updated: August 1, 2017
• Results First Posted: October 12, 2015

Record last verified: 2017-06

Locations

PE (4)