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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03112213
Date of registration:	10/04/2017
Prospective Registration:	No
Primary sponsor:	Hoffmann-La Roche
Public title:	Characterization of Non-Steroidal Anti-Inflammatory Drug (NSAID) Intake in Rheumatoid Arthritis (RA) Participants on Tocilizumab (RoACTEMRA®) Treatment CONIFER
Scientific title:	CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)
Date of first enrolment:	January 12, 2017
Target sample size:	135
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03112213
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Germany

Contacts

Name:	Clinical Trials
Address:
Telephone:
Email:
Affiliation:	Hoffmann-La Roche

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: NSAIDs

Drug: Tocilizumab

Primary Outcome(s)

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

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]

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]

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]

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]

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)]

Secondary Outcome(s)

Average Daily Dose of NSAIDs [Time Frame: Day -14 up to approximately Day 126]

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]

Percentage of Participants Using NSAIDs by Disease Activity [Time Frame: Day -14 up to approximately Day 126]

Percentage of NSAID-Prescribers [Time Frame: Day -14 up to approximately Day 126]

Percentage of Participants Who Take NSAIDs [Time Frame: Day -14 up to approximately Day 126]

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]

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

Percentage of Participants Using NSAIDs by Disease Duration [Time Frame: Day -14 up to approximately Day 126]

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

HAQ-DI Score [Time Frame: Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16]

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]

Percentage of Participants With Adverse Events (AEs) [Time Frame: From Baseline up to approximately Week 28]

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]

Percentage of NSAID Self-Medication [Time Frame: Day -14 up to approximately Day 126]

Secondary ID(s)

ML30088

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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