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Completed

NCT Number: NCT03112213

Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment

This nationwide, multicenter, single arm, prospective, non-interventional study will evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use in a representative cohort of participant with moderate to severe active RA who have either responded inadequately to, or who were intolerant to previous therapy with one or more synthetic disease modifying anti-rheumatic drug (sDMARD), and for whom the physician has made the individual decision to initiate tocilizumab (subcutaneous [SC] or intravenous [IV]) as first biological disease modifying anti-rheumatic drug (DMARD) therapy according to the summary of product characteristics (SPC).

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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

Rheumazentrum Kupka, Altenburg, Germany

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Participants with moderate to severe active RA who have either responded inadequately to, or who were intolerant to, previous therapy with one or more sDMARDs and for whom the physician has made the individual decision to be treated with tocilizumab (SC or IV)
  • Current users of NSAIDs due to RA as assessed by the physician

Exclusion criteria

  • Contraindications to treatment with tocilizumab as per SPC
  • Prior therapy with tocilizumab

Treatment and study plan

Tocilizumab

Drug

Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.

Other names: RoACTEMRA®

NSAIDs

Drug

Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.

Primary outcomes

  1. Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration

    Time frame: Day -14 to Day 0 (Baseline)

  2. Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration

    Time frame: 14 days after 6-8 weeks of tocilizumab administration

  3. Amount of NSAIDs Used During 14 Days After 12-16 Weeks of Tocilizumab Administration

    Time frame: 14 days after 12-16 weeks of tocilizumab administration

  4. Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days Prior to First Tocilizumab Administration

    Time frame: Day -14 to Day 0 (Baseline)

    NSAIDs high-dose refers to mean defined daily dose (DDD) greater than (>) 100 percent (%) and low-dose refers to mean DDD lesser than or equal to (</=) 100%.

  5. Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 6-8 Weeks of Tocilizumab Administration

    Time frame: 14 days after 6-8 weeks of tocilizumab administration

    NSAIDs high-dose refers to mean DDD >100% and low-dose refers to mean DDD </=100%.

  6. Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 14 Days After 12-16 Weeks of Tocilizumab Administration

    Time frame: 14 days after 12-16 weeks of tocilizumab administration

    NSAIDs high-dose refers to mean DDD >100% and low-dose refers to mean DDD </=100%.

Secondary outcomes

  1. Percentage of Participants Who Take NSAIDs

    Time frame: Day -14 up to approximately Day 126

  2. Average Daily Dose of NSAIDs

    Time frame: Day -14 up to approximately Day 126

  3. Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors

    Time frame: Day -14 up to approximately Day 126

  4. Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs

    Time frame: Day -14 up to approximately Day 126

  5. Percentage of NSAID-Prescribers

    Time frame: Day -14 up to approximately Day 126

  6. Percentage of NSAID Self-Medication

    Time frame: Day -14 up to approximately Day 126

  7. Percentage of Participants Using NSAIDs by Disease Activity

    Time frame: Day -14 up to approximately Day 126

  8. Percentage of Participants Using NSAIDs by Disease Duration

    Time frame: Day -14 up to approximately Day 126

  9. Percentage of Participants Using NSAIDs by Health Assessment Questionnaire-Disability Index (HAQ-DI) Score

    Time frame: Day -14 up to approximately Day 126

  10. HAQ-DI Score

    Time frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16

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

    Time frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16

  12. Clinical Disease Activity Index (CDAI) Score

    Time frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16

  13. Simplified Disease Activity Index (SDAI) Score

    Time frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16

  14. Percentage of Participants With Adverse Events (AEs)

    Time frame: From Baseline up to approximately Week 28

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)

Acronym: CONIFER

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 13, 2017
Registry last updated
Dec 13, 2018

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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