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

Hoffmann-La Roche16 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis

Interventions

TocilizumabBIOLOGICAL

Tocilizumab was administered according to the local label.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

ABK Reuma SRL- Medicentro BioCiencias

Lima, Peru

Hospital de la Mujer

Lima, Peru

Clinica San Borja; Servicio De Reumatologia

Lima, Peru

Clinica El Golf

San Isidro, Peru

Outcomes

Primary Outcomes

Number of Participants on Tocilizumab at 6 Months After Treatment Initiation

Time frame: At 6 months

Secondary Outcomes

Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis

Systemic manifestation measured by C-reactive protein levels \> 3

Time frame: 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.

Time frame: At baseline

Number of Participants Starting Tocilizumab After Failing Other Biologic Agents

Other biologic agents include anti-Tumor Necrosis Factor (TNF) antibody.

Time frame: At baseline

Median Dose at 6 Months

Time frame: At 6 months

Number of Participants With Dose Modifications at 6 Months

Time frame: At 6 months

Median Duration of Treatment

Time frame: 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.

Data from ClinicalTrials.gov

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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.

Time frame: 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