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

Rheumatoid Arthritis Clinical Trial

Official title:

A Multi-national, Multi-center Non-interventional Study in Rheumatoid Arthritis (RA) Patients Treated With Tocilizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01741688
• Other study ID #: ML28206
• Status: Completed
• Phase: N/A
• First received: November 30, 2012
• Last updated: September 9, 2015
• Start date: October 2012
• Est. completion date: March 2014

Study information

• Verified date: September 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Peru: Instituto Nacional de Salud
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients, >/= 18 years of age

• Moderate to severe rheumatoid arthritis according to the revised (1987) American College of Rheumatology (ACR) criteria

• Patients in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label); this can include patients who have received tocilizumab treatment within 8 weeks prior to the enrolment visit

Exclusion Criteria:

• Patients who have received tocilizumab more than 8 weeks prior to the enrolment visit

• Patients 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

• Patients with a history of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Other:
• No intervention
No intervention was administered in this study

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants on Tocilizumab at 6 Months After Treatment Initiation		At 6 months	No
Secondary	Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis	Systemic manifestation measured by C-reactive protein levels > 3	At baseline	No
Secondary	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	No
Secondary	Number of Participants Starting Tocilizumab After Failing Other Biologic Agents	Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.	At baseline	No
Secondary	Median Dose at 6 Months		At 6 months	No
Secondary	Number of Participants With Dose Modifications at 6 Months		At 6 months	No
Secondary	Median Duration of Treatment		Approximately 16 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Time to Restoration of Initial Dosing Regimen		Approximately 16 months	No
Secondary	Non-adherence Rate of Physician to the Recommended Dosing Regimen		Approximately 16 months	No
Secondary	Percentage of Participants on Tocilizumab Monotherapy at Study Entry		At baseline	No
Secondary	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	No
Secondary	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	No
Secondary	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), 2) count the number of tender joints (out of the 28), 3) measure Erythrocyte Sedimentation Rate, and 4) ask the participant to make a 'global assessment of health' (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	No