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Completed

NCT Number: NCT03291457

A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice

This prospective, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks after starting treatment with tocilizumab. All visits and assessments will be performed as per routine clinical practice, with no study-specific visits or interventions.

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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

ASZ Aalst, Aalst, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of moderate to severe RA, defined as DAS28 greater than or equal to 3.7
  • Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment
  • Physician has made decision to commence IV or SC tocilizumab in accordance with label and reimbursement criteria
  • Treated with glucocorticoids for RA when starting tocilizumab treatment

Exclusion criteria

  • Treatment with any investigational agent within 4 weeks or 5 half-lives before tocilizumab
  • Continuous or regular treatment with oral corticosteroids for any indication other than RA

Treatment and study plan

Tocilizumab

Drug

For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.

Other names: RoActemra

Glucocorticoid Agent

Drug

Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.

Primary outcomes

  1. Percentage of Participants Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28)

    Time frame: Week 52

  2. Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28

    Time frame: Week 52

  3. Percentage of Participants by Reason for Glucocorticoid Dose Modification

    Time frame: Baseline up to Week 52

Secondary outcomes

  1. Glucocorticoid Dose

    Time frame: Baseline; Weeks 24 and 52

  2. Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%

    Time frame: Weeks 24 and 52

  3. Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%

    Time frame: Weeks 24 and 52

  4. Time to First Glucocorticoid Dose Reduction

    Time frame: Baseline up to Week 52

  5. Time to Glucocorticoid Discontinuation

    Time frame: Baseline up to Week 52

  6. Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction

    Time frame: Baseline up to Week 52

  7. Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%

    Time frame: Baseline up to Week 52

  8. Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids

    Time frame: Baseline up to Week 52

  9. Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction

    Time frame: Baseline up to Week 52

  10. Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%

    Time frame: Baseline up to Week 52

  11. Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids

    Time frame: Baseline up to Week 52

  12. Glucocorticoid Dose among Participants in Remission According to DAS28

    Time frame: Baseline up to Week 52

  13. Glucocorticoid Dose among Participants with LDA According to DAS28

    Time frame: Baseline up to Week 52

  14. Correlation between DAS28 Score and Glucocorticoid Dose

    Time frame: Baseline up to Week 52

  15. Percentage of Participants with Adverse Events

    Time frame: Baseline up to Week 52

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice

Acronym: COGNOS

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Sep 25, 2017
Registry last updated
May 18, 2020

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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