A Study of Tocilizumab in Participants With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Non-Biological Disease-modifying Anti-rheumatic Drugs (DMARDs)

NCT01617005 | Completed Results

• 1 other identifier: ML25699
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study will evaluate the safety and efficacy of tocilizumab in participants with active moderate to severe RA and an inadequate response to non-biologic DMARDs. Data will be collected from each eligible participant initiating tocilizumab treatment over 6 months.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

  An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs include both SAEs as well as non-serious AEs.

  Baseline up to Week 24

Secondary Outcomes (3)

• Number of Participants With Good or Moderate Response According to European League Against Rheumatism (EULAR) Criteria

  Baseline, Week 24

• Number of Participants Who Discontinued Treatment Due to Lack of Efficacy

  Baseline up to Week 24

• Time to Discontinuation Due to Lack of Efficacy

  Baseline up to Week 24

Study Arms (1)

Tocilizumab in Moderate to Severe Active RA

Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), will be observed. The choice of therapy will be based exclusively on the medical decision of the treating physician before study enrollment. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.

Also known as: RoActemra, L04AC07

Tocilizumab in Moderate to Severe Active RA

Eligibility Criteria

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

Study Population

Participants with RA and an inadequate response to non-biologic DMARDs.

You may qualify if:

• Moderate to severe active RA (European League Against Rheumatism \[EULAR\] criteria)
• Inadequate response to DMARDs or tumor necrosis factor (TNF) antagonists
• Initiating treatment with tocilizumab according to SPC

You may not qualify if:

• Rheumatic autoimmune disease other than RA
• Prior history or current inflammatory joint disease other than RA
• Previous treatment with any biological drug used in the treatment of RA
• Previous treatment with tocilizumab
• Any contraindication to treatment with tocilizumab
• Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment
• Pregnant women or nursing (breastfeeding) mothers

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Podgorica, 81000, Montenegro

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

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: June 8, 2012
• First Posted: June 12, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: December 1, 2016
• Results First Posted: December 1, 2016

Record last verified: 2016-10

Locations

MO (1)