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

December 12, 2018 updated by: Hoffmann-La Roche

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
135

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Altenburg, Germany, 04600
        • Rheumazentrum Kupka
      • Amberg, Germany, 92224
        • Praxis für Rheumatologie.
      • Bad Nauheim, Germany, 61231
        • Kerckhoff-Klinik; Rheumatologie&klin.Immunologie
      • Berlin, Germany, 10117
        • Charité Campus Mitte, Med.Klinik, Rheumatologie und Klinische Immunologie
      • Berlin, Germany, 12435
        • Praxis für Innere Medizin - Rheumatologie
      • Berlin, Germany, 12435
        • Rheuma Praxis Berlin Sven Remstedt
      • Berlin, Germany, 13055
        • Praxis Dr. Silke Zinke
      • Burghausen, Germany, 84489
        • Schwerpunktpraxis für Rheumatologie und klinische Immunologie an den Kreiskliniken
      • Dresden, Germany, 01307
        • Universitätsklinikum "Carl Gustav Carus"; Medizinische Klinik III
      • Güstrow, Germany, 18273
        • Praxis Dr. med. Semmler; Facharzt für Innere Medizin
      • Halle, Germany, 06128
        • Dres.Karin Babinsky und Anke Liebhaber
      • Hamburg/Poppenbüttel, Germany, 22391
        • Praxis für Rheumatologie Dr. med. Hauke E. Heintz
      • Hannover, Germany, 30161
        • Rheumatologische Schwerpunktpraxis
      • Heidelberg, Germany, 69120
        • Rheumapraxis PD Dr.med. Bernhard Heilig
      • Magdeburg, Germany, 39104
        • Rheumatologische Facharztpraxis Maren Sieburg
      • Mansfeld, Germany, 06343
        • Praxis fur Innere Medizin und Rheumatologie
      • Muenchen, Germany, 81541
        • Praxiszentrum St. Bonifatius
      • München, Germany, 80935
        • Praxis Prof. Dr.med. Herbert Kellner
      • Neubrandenburg, Germany, 17033
        • Rheumatologische Praxis
      • Neuss, Germany, 41460
        • Rheumazentrum Neuss Dres. Irmgard Gürtler und Christoph Volberg
      • Neuss, Germany, 41462
        • Praxis Dr.med. Christoph Volberg
      • Offenburg, Germany, 77652
        • Praxis Dr. Albert
      • Püttlingen, Germany, 66346
        • Knappschaftsklinikum Saar GmbH, Krankenhaus Püttlingen
      • Ratingen, Germany, 40878
        • Rheumazentrum Ratingen - Studienambulanz
      • Saarbruecken, Germany, 66111
        • Praxis Dr.med. Werner A. Biewer
      • Stuttgart, Germany, 70178
        • Rheumatologische Schwerpunktpraxis am Feuersee
      • Ulm, Germany, 89073
        • Praxis für Rheumatologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Amount of NSAIDs Used During 14 Days Prior to First Tocilizumab Administration
Time Frame: Day -14 to Day 0 (Baseline)
Day -14 to Day 0 (Baseline)
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
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
14 days after 12-16 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)
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%.
Day -14 to Day 0 (Baseline)
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%.
14 days after 6-8 weeks of tocilizumab administration
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%.
14 days after 12-16 weeks of tocilizumab administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants Who Take NSAIDs
Time Frame: Day -14 up to approximately Day 126
Day -14 up to approximately Day 126
Average Daily Dose of NSAIDs
Time Frame: Day -14 up to approximately Day 126
Day -14 up to approximately Day 126
Percentage of Participants Who Take NSAIDs Despite the Presence of Contraindications and Risk Factors
Time Frame: Day -14 up to approximately Day 126
Day -14 up to approximately Day 126
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
Day -14 up to approximately Day 126
Percentage of NSAID-Prescribers
Time Frame: Day -14 up to approximately Day 126
Day -14 up to approximately Day 126
Percentage of NSAID Self-Medication
Time Frame: Day -14 up to approximately Day 126
Day -14 up to approximately Day 126
Percentage of Participants Using NSAIDs by Disease Activity
Time Frame: Day -14 up to approximately Day 126
Day -14 up to approximately Day 126
Percentage of Participants Using NSAIDs by Disease Duration
Time Frame: Day -14 up to approximately Day 126
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
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
Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
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
Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
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
Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
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
Screening (up to 28 days prior to first tocilizumab administration); Day 0 (Baseline); Weeks 6-8; Weeks 12-16
Percentage of Participants With Adverse Events (AEs)
Time Frame: From Baseline up to approximately Week 28
From Baseline up to approximately Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 12, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML30088

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Rheumatoid Arthritis

Clinical Trials on Tocilizumab

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings