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

A Multi-National, Multi-Center Non-Interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Biological: Tocilizumab

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• Peru
  • Lima, Peru, Lima 41
    • Clinica San Borja; Servicio De Reumatologia
  • Lima, Peru, Lima 21
    • ABK Reuma SRL- Medicentro BioCiencias
  • Lima, Peru, Lima 34
    • Hospital de la Mujer
  • San Isidro, Peru, L27 Lima
    • Clinica El Golf

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Participants with rheumatoid arthritis (RA) initiated on treatment with tocilizumab

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Tocilizumab was administered according to the local label.; Other Names: Actemra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants on Tocilizumab at 6 Months After Treatment Initiation	At 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis	Systemic manifestation measured by C-reactive protein levels > 3	At baseline
Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure	DMARDs exposure was evaluated for all participants. "Prior DMARDs treatment" includes participants, who were treated with DMARDs 6 months before being included in the study. "DMARDs treatment at baseline" includes participants, who were receiving DMARDs when they were included in the study and continued with this concomitant medication to tocilizumab.	At baseline
Number of Participants Starting Tocilizumab After Failing Other Biologic Agents	Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.	At baseline
Median Dose at 6 Months		At 6 months
Number of Participants With Dose Modifications at 6 Months		At 6 months
Median Duration of Treatment		Approximately 16 months
Percentage of Participants Discontinued From Tocilizumab for Safety	Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.	Approximately 16 months
Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy	Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.	Approximately 16 months
Number of Participants Discontinued From Tocilizumab for Other Reasons	This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.	Approximately 16 months
Time to Restoration of Initial Dosing Regimen		Approximately 16 months
Non-adherence Rate of Physician to the Recommended Dosing Regimen		Approximately 16 months
Percentage of Participants on Tocilizumab Monotherapy at Study Entry		At baseline
Total Tender Joint Count (TJC)		At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks
Total Swollen Joint Count (SJC)		At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks
Disease Activity Score Based on 28 Joints (DAS28)	The DAS28 is a measure of disease activity in rheumatoid arthritis (RA) and the number 28 refers to the 28 joints that are examined in this assessment. To calculate the DAS28 the following assessments are done: 1) count the number of swollen joints (out of the 28 [sw28]), 2) count the number of tender joints (out of the 28 [t28]), 3) measure Erythrocyte Sedimentation Rate (ESR), and 4) ask the participant to make a 'global assessment of health' (GH) indicated by marking a 10 cm line between very good and very bad. The Score is developed under the follow formula: DAS28(4) = 0.56*sqrt(t28) + 0.28*sqrt(sw28) + 0.70*Ln(ESR) + 0.014*GH Where, t=tender joints; sw=swollen joints; ESR= Erythrocyte Sedimentation Rate; GH=Global assessment of health score. This score may range from 0 to 9.3, where a DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.	At Visit 1 (Baseline), Observation 1: up to 4 weeks, Observation 2: up to 8 weeks; Observation 3: up to 12 weeks; Observation 4: up to 16 weeks and Observation 5: up to 20 weeks

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): October 26, 2012
• Primary Completion (Actual): March 6, 2014
• Study Completion (Actual): March 6, 2014

Study Registration Dates

• First Submitted: November 30, 2012
• First Submitted That Met QC Criteria: December 3, 2012
• First Posted (Estimate): December 5, 2012

Study Record Updates

• Last Update Posted (Actual): August 1, 2017
• Last Update Submitted That Met QC Criteria: June 27, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML28206