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Rheumatoid ArthritisCONIFERNCT03112213

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

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 27 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
Tocilizumab and NSAIDs
Type of treatment
Injection or infusion
How many people
135 participants
Where
27 sitesGermany
Study dates
12 Jan 2017to 17 Jul 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

Germany27 sites

  • Rheumazentrum Kupka

    Altenburg, 04600

  • Praxis für Rheumatologie.

    Amberg, 92224

  • Kerckhoff-Klinik; Rheumatologie&klin.Immunologie

    Bad Nauheim, 61231

  • Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie

    Berlin, 10117

  • Praxis für Innere Medizin - Rheumatologie

    Berlin, 12435

  • Rheuma Praxis Berlin Sven Remstedt

    Berlin, 12435

  • Praxis Dr. Silke Zinke

    Berlin, 13055

  • Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken

    Burghausen, 84489

  • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III

    Dresden, 01307

  • Praxis Dr. med. Semmler; Facharzt für Innere Medizin

    Güstrow, 18273

  • Dres.Karin Babinsky und Anke Liebhaber

    Halle, 06128

  • Rheumatologische Schwerpunktpraxis

    Hanover, 30161

  • Rheumapraxis PD Dr.med. Bernhard Heilig

    Heidelberg, 69120

  • Rheumatologische Facharztpraxis Maren Sieburg

    Magdeburg, 39104

  • Praxis für Innere Medizin und Rheumatologie

    Mansfeld, 06343

  • Praxis Prof. Dr.med. Herbert Kellner

    München, 80935

  • Praxiszentrum St. Bonifatius

    München, 81541

  • Rheumatologische Praxis

    Neubrandenburg, 17033

  • Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg

    Neuss, 41460

  • Praxis Dr.med. Christoph Volberg

    Neuss, 41462

  • Praxis Dr. Albert

    Offenburg, 77652

  • Praxis für Rheumatologie Dr. med. Hauke E. Heintz

    Poppenbüttel, 22391

  • Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen

    Püttlingen, 66346

  • Rheumazentrum Ratingen - Studienambulanz

    Ratingen, 40878

  • Praxis Dr.med. Werner A. Biewer

    Saarbrücken, 66111

  • Rheumatologische Schwerpunktpraxis am Feuersee

    Stuttgart, 70178

  • Praxis für Rheumatologie

    Ulm, 89073

Other trials in Germany

About this study

Official title: CONIFER (Characterization of NSAID Intake for Established Rheumatoid Arthritis)

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).

Being tested
Tocilizumab, NSAIDs
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TocilizumabDrug

    Also called RoACTEMRA®

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

  • NSAIDsDrug

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

Study groups in NCT03112213
Study groupRoleWhat they receive
Participants With RAParticipants 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.
Receives: Drug: Tocilizumab; Drug: NSAIDs

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day -14 to Day 0 (Baseline)

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

    Measured: 14 days after 6-8 weeks of tocilizumab administration

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

    Measured: 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

    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%.

    Measured: Day -14 to Day 0 (Baseline)

  5. Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 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%.

    Measured: 14 days after 6-8 weeks of tocilizumab administration

  6. Percentage of Participants by NSAIDs Dose Categories (Low-Dose and High-Dose) During 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%.

    Measured: 14 days after 12-16 weeks of tocilizumab administration

Secondary outcomes (14)

  1. Percentage of Participants Who Take NSAIDs

    Measured: Day -14 up to approximately Day 126

  2. Average Daily Dose of NSAIDs

    Measured: Day -14 up to approximately Day 126

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

    Measured: Day -14 up to approximately Day 126

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

    Measured: Day -14 up to approximately Day 126

  5. Percentage of NSAID-Prescribers

    Measured: Day -14 up to approximately Day 126

  6. Percentage of NSAID Self-Medication

    Measured: Day -14 up to approximately Day 126

  7. Percentage of Participants Using NSAIDs by Disease Activity

    Measured: Day -14 up to approximately Day 126

  8. Percentage of Participants Using NSAIDs by Disease Duration

    Measured: Day -14 up to approximately Day 126

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

    Measured: Day -14 up to approximately Day 126

  10. HAQ-DI Score

    Measured: 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)

    Measured: 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

    Measured: 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

    Measured: 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)

    Measured: From Baseline up to approximately Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2017
  2. Study start12 Jan 2017
  3. Primary completion17 Jul 2018
  4. Study completion17 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
135 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03112213
Sponsor's protocol ID
ML30088
Acronym
CONIFER
Status last verified
Dec 2018
First submitted
10 Apr 2017
Last updated
13 Dec 2018
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 27 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration (time frame: Day -14 to Day 0 (Baseline)). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03112213.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2018.

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