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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT03112213
Collaborator
(none)
135
Enrollment
27
Locations
18.1
Actual Duration (Months)
5
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
135 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)
Actual Study Start Date :
Jan 12, 2017
Actual Primary Completion Date :
Jul 17, 2018
Actual Study Completion Date :
Jul 17, 2018

Arms and Interventions

Arm Intervention/Treatment
Participants With RA

Participants with RA who are being treated with tocilizumab and NSAIDs will be observed for approximately 6 months to evaluate the quantitative pattern of NSAID use and the impact of treatment with tocilizumab on NSAID use.

Drug: Tocilizumab
Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.
Other Names:
  • RoACTEMRA®

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

    Outcome Measures

    Primary Outcome Measures

    1. Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration [Day -14 to Day 0 (Baseline)]

    2. Amount of NSAIDs Used During 14 Days After 6-8 Weeks of Tocilizumab Administration [14 days after 6-8 weeks of tocilizumab administration]

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

    1. Percentage of Participants Who Take NSAIDs [Day -14 up to approximately Day 126]

    2. Average Daily Dose of NSAIDs [Day -14 up to approximately Day 126]

    3. Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors [Day -14 up to approximately Day 126]

    4. Percentage of Participants Who do not Take Gastro-Protection (Proton-Pump Inhibitors [PPIs]) While Using NSAIDs [Day -14 up to approximately Day 126]

    5. Percentage of NSAID-Prescribers [Day -14 up to approximately Day 126]

    6. Percentage of NSAID Self-Medication [Day -14 up to approximately Day 126]

    7. Percentage of Participants Using NSAIDs by Disease Activity [Day -14 up to approximately Day 126]

    8. Percentage of Participants Using NSAIDs by Disease Duration [Day -14 up to approximately Day 126]

    9. Percentage of Participants Using NSAIDs by Health Assessment Questionnaire-Disability Index (HAQ-DI) Score [Day -14 up to approximately Day 126]

    10. HAQ-DI Score [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) [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 [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 [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) [From Baseline up to approximately Week 28]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rheumazentrum Kupka Altenburg Germany 04600
    2 Praxis für Rheumatologie. Amberg Germany 92224
    3 Kerckhoff-Klinik; Rheumatologie&klin.Immunologie Bad Nauheim Germany 61231
    4 Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie Berlin Germany 10117
    5 Praxis für Innere Medizin - Rheumatologie Berlin Germany 12435
    6 Rheuma Praxis Berlin Sven Remstedt Berlin Germany 12435
    7 Praxis Dr. Silke Zinke Berlin Germany 13055
    8 Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken Burghausen Germany 84489
    9 Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III Dresden Germany 01307
    10 Praxis Dr. med. Semmler; Facharzt für Innere Medizin Güstrow Germany 18273
    11 Dres.Karin Babinsky und Anke Liebhaber Halle Germany 06128
    12 Praxis für Rheumatologie Dr. med. Hauke E. Heintz Hamburg/Poppenbüttel Germany 22391
    13 Rheumatologische Schwerpunktpraxis Hannover Germany 30161
    14 Rheumapraxis PD Dr.med. Bernhard Heilig Heidelberg Germany 69120
    15 Rheumatologische Facharztpraxis Maren Sieburg Magdeburg Germany 39104
    16 Praxis für Innere Medizin und Rheumatologie Mansfeld Germany 06343
    17 Praxiszentrum St. Bonifatius Muenchen Germany 81541
    18 Praxis Prof. Dr.med. Herbert Kellner München Germany 80935
    19 Rheumatologische Praxis Neubrandenburg Germany 17033
    20 Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg Neuss Germany 41460
    21 Praxis Dr.med. Christoph Volberg Neuss Germany 41462
    22 Praxis Dr. Albert Offenburg Germany 77652
    23 Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen Püttlingen Germany 66346
    24 Rheumazentrum Ratingen - Studienambulanz Ratingen Germany 40878
    25 Praxis Dr.med. Werner A. Biewer Saarbruecken Germany 66111
    26 Rheumatologische Schwerpunktpraxis am Feuersee Stuttgart Germany 70178
    27 Praxis für Rheumatologie Ulm Germany 89073

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03112213
    Other Study ID Numbers:
    • ML30088
    First Posted:
    Apr 13, 2017
    Last Update Posted:
    Dec 13, 2018
    Last Verified:
    Dec 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Arthritis
    Arthritis, Rheumatoid

    Study Results

    No Results Posted as of Dec 13, 2018