Observational Study of Tocilizumab in Participants With Rheumatoid Arthritis in Australia

NCT01683604 | Completed Results

• 1 other identifier: ML28144
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 7

Brief Summary

This multi-center, observational study will evaluate the treatment patterns in clinical practice, efficacy and safety of tocilizumab in participants with rheumatoid arthritis (RA) who have had an inadequate response (or were intolerant to) treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent. Data will be collected from each eligible participant initiated on tocilizumab treatment by their treating physician according to approved label for 6 months from start of treatment.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (8)

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

  Percentage of participants on tocilizumab treatment at Month 6 was calculated as: \[(participants on tocilizumab treatment at Month 6) divided by (participants evaluable for primary objective)\] multiplied by 100.

  Month 6

• Patient Assessment of Pain Using Visual Analog Scale (VAS) at Baseline

  Participants measured the pain intensity due to RA on a 100 millimeter (mm) VAS, where the responses were on a continuous range from 0 = no pain to 100 = unbearable pain.

  Baseline

• Patient Global Assessment of Disease Activity Using VAS at Baseline

  The patient's global assessment of disease activity was measured using a 100 mm VAS, where the responses were on a continuous range from 0 = managing very well to 100 = managing very poorly.

  Baseline

• Physician Global Assessment of Disease Activity Using VAS at Baseline

  Physician global assessment of disease activity was assessed on a 100 mm VAS, where 0 = no arthritis activity to 100 = extremely active arthritis.

  Baseline

• Health Assessment Questionnaire Disability Index (HAQ-DI) Scores at Baseline

  The HAQ-DI is a questionnaire that measures functional status (disability) and health-related quality of life. It measures the participant's ability to perform everyday tasks. The index consists of 20 questions regarding the function of the upper and lower extremities. These questions are summarized in 8 categories: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and common activities over past week. Each question is evaluated according to the degree of severity on a 4-point scale. Total score for HAQ-DI is the average of all questions and ranges from 0 = without any difficulty to 3 = unable to do.

  Baseline

• Tender Joint Count (TJC) and Swollen Joint Count (SJC) at Baseline

  TJC was determined by examining 28 and 68 joints and identifying the joints that were painful under pressure or to passive motion. Tenderness was recorded on the joint assessment form at baseline, no tenderness = 0, tenderness = 1. SJC was determined by examining 28 and 66 joints and identifying when swelling was present. Swelling was recorded on the joint assessment form at baseline, no swelling = 0, swelling =1.

  Baseline

• Erythrocyte Sedimentation Rate (ESR) at Baseline

  ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube. Normal range is 0-30 millimeters per hour (mm/hr). A decrease in the level indicates reduction in inflammation and therefore improvement.

  Baseline

• C-Reactive Protein (CRP) at Baseline

  The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement.

  Baseline

Secondary Outcomes (24)

• Percentage of Participants Starting Tocilizumab After Stopping a Biologic Treatment or After Failing DMARDs

  Baseline

• Median Dose at Month 6

  Month 6

• Percentage of Participants With Tocilizumab Dose Changed According to the Reason for Change

  Baseline up to Month 6

• Mean Dosing Interval at Month 6

  Month 6

• Percentage of Participants With Reasons Who Discontinued Tocilizumab

  Baseline up to Month 6

Study Arms (1)

Rheumatoid Arthritis (RA) Participants (All Groups)

Participants with severe RA were prescribed with tocilizumab in accordance with routine clinic practice, and were observed for 6 months.

Other: Observational study

Interventions

Observational study OTHER

Rheumatoid Arthritis (RA) Participants (All Groups)

Eligibility Criteria

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

Study Population

RA participants treated with tocilizumab

You may qualify if:

• Severe RA.
• Inadequate response (or intolerant) to non-biological DMARDs or one biologic agent
• Participants initiating treatment with tocilizumab on their physician's decision (in accordance with the local label), including participants who started treatment with tocilizumab within the 8 weeks prior to the enrolment visit.

You may not qualify if:

• Tocilizumab treatment more than 8 weeks prior to the enrolment visit.
• Previous tocilizumab treatment in a clinical trial or for compassionate use.
• Enrolled in an ongoing clinical trial and/or 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 RA.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Unknown Facility

Campsie, New South Wales, 2194, Australia

Location

Unknown Facility

Coffs Harbour, New South Wales, 2450, Australia

Location

Unknown Facility

New Lambton, New South Wales, 2305, Australia

Location

Unknown Facility

Woodville, South Australia, 5011, Australia

Location

Unknown Facility

Heidelberg, Victoria, 3084, Australia

Location

Unknown Facility

Morwell, Victoria, 3842, Australia

Location

Unknown Facility

Shenton Park, Western Australia, 6008, Australia

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Observation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Results Point of Contact

• Title: Medical Communications
• Organization: HoffmannLaRoche

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: September 5, 2012
• First Posted: September 12, 2012
• Study Start: July 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 21, 2016
• Results First Posted: July 21, 2016

Record last verified: 2016-06

Locations

AU (7)