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Completed

NCT Number: NCT01741688

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ABK Reuma SRL- Medicentro BioCiencias, Lima, Peru

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tocilizumab

Biological

Tocilizumab was administered according to the local label.

Other names: Actemra

Primary outcomes

  1. Number of Participants on Tocilizumab at 6 Months After Treatment Initiation

    Time frame: At 6 months

Secondary outcomes

  1. Percentage of Participants With Systemic Manifestations of Rheumatoid Arthritis

    Time frame: At baseline

    Systemic manifestation measured by C-reactive protein levels > 3

  2. Percentage of Participants Starting Tocilizumab After Prior and Baseline Disease-Modifying Anti-rheumatic Drugs (DMARDs) Exposure

    Time frame: At baseline

    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.

  3. Number of Participants Starting Tocilizumab After Failing Other Biologic Agents

    Time frame: At baseline

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

  4. Median Dose at 6 Months

    Time frame: At 6 months

  5. Number of Participants With Dose Modifications at 6 Months

    Time frame: At 6 months

  6. Median Duration of Treatment

    Time frame: Approximately 16 months

  7. Percentage of Participants Discontinued From Tocilizumab for Safety

    Time frame: Approximately 16 months

    Safety variable measuring number of patients that discontinued tocilizumab due to adverse reactions to tocilizumab.

  8. Percentage of Participants Discontinued From Tocilizumab for Lack of Efficacy

    Time frame: Approximately 16 months

    Efficacy variable that measures the rate of participants discontinued from tocilizumab due to lack of efficacy according to criteria of treating physician.

  9. Number of Participants Discontinued From Tocilizumab for Other Reasons

    Time frame: Approximately 16 months

    This variable measures the number of events not related to safety or efficacy leading to discontinuation of tocilizumab treatment.

  10. Time to Restoration of Initial Dosing Regimen

    Time frame: Approximately 16 months

  11. Non-adherence Rate of Physician to the Recommended Dosing Regimen

    Time frame: Approximately 16 months

  12. Percentage of Participants on Tocilizumab Monotherapy at Study Entry

    Time frame: At baseline

  13. Total Tender Joint Count (TJC)

    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

  14. Total Swollen Joint Count (SJC)

    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

  15. Disease Activity Score Based on 28 Joints (DAS28)

    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

    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.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 5, 2012
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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