A Comparative Study to Observe the Effect of Concomitant Use of Corticosteroid Treatment in Rheumatoid Arthritis (RA) Participants Who Are Treated With a Tumor Necrosis Factor (TNF) Inhibitor or Tocilizumab (TCZ) as Their Second Biological Treatment.

July 24, 2018 updated by: Hoffmann-La Roche

A COMPARATIVE OBSERVATIONAL STUDY FOLLOWING THE USE OF CONCOMITANT CORTICOSTEROID TREATMENT IN RA PATIENTS WHO ARE TREATED WITH A TNF INHIBITOR OR TOCILIZUMAB AS THEIR SECOND BIOLOGICAL TREATMENT

This six months non-interventional, observational, post-marketing, multi-center and local study will evaluate the differences in the use of corticosteroids between RA participants receiving TCZ or a TNF-inhibitor, in participants who have discontinued the use of a TNF-inhibitor as their first biological treatment.

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.
200

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

  • Sweden
      • Arvika, Sweden, 671 80
        • Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen
      • Eskilstuna, Sweden, 631 88
        • Mälarsjukhuset; Reumatologkliniken
      • Huddinge, Sweden, SE-141 86
        • Karolinska University Hospital, Huddinge; Rheumatology
      • Karlskrona, Sweden, 37185
        • Blekingesjukhuset Karlskrona; Medicin, Rheumatology
      • Malmo, Sweden, 205 02
        • Skånes Universitetssjukhus Malmö; Reumatologkliniken
      • Malmö, Sweden, 212 28
        • Capio Citykliniken, Reumatologen
      • Oerebro, Sweden, 70185
        • Örebro Uni Hospital; Rheumatology
      • Skoevde, Sweden, 54185
        • Kaernsjukhuset; Dept of Medicine
      • Stockholm, Sweden, 18288
        • Danderyds Sjukhus Ab; Rheumatology
      • Trelleborg, Sweden, 231 85
        • Lasarettet Trelleborg;Reumatologmottagningen
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset, Reumatologkliniken

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

Sampling Method

Non-Probability Sample

Study Population

Participants with a diagnosis of moderate to severe RA according to the revised (1987) ACR criteria or 2010 ACR/EULAR RA classification criteria who have had an insufficient response or intolerance to their first TNF-inhibitor.

Description

Inclusion Criteria:

  • At least 18 years of age.
  • With a diagnosis of moderate to severe RA according to the revised (1987) American College of Rheumatology (ACR) criteria or 2010 ACR/ European League Against Rheumatism (EULAR) RA classification criteria.
  • Have had an insufficient response or intolerance to their first TNF-inhibitor (including biosimilars for TNF-inhibitors).
  • The treating physician has made the decision to commence TCZ or TNF-inhibitor treatment. Participants need to have a Disease Activity Score (DAS) 28 assessment at initiation of their second biological treatment.
  • Have been given oral and written information about the study and have no objection to the data concerning him/her being subject to computerized data processing, have given informed consent.

Exclusion Criteria:

  • Have had more than one TNF-inhibitor prior to the enrolment visit.
  • Have had biological treatment other than TNF-inhibitors.
  • Participants that are continuously treated with per oral corticosteroids for any other indication than RA (at baseline).

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

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.
RA participants treated with a TNF inhibitor or TCZ
Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling will be observed.
Drug: TNF inhibitor/TCZ
Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current SPC/local labeling will be observed.
Other Names:
  • COTTON

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
Time Frame
Percentage of participants with a decrease in dose of oral corticosteroids during the study
Time Frame: From baseline to 6 months
From baseline to 6 months

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 achieving C59CDAI remission (</=2.8)
Time Frame: From baseline to 6 months
From baseline to 6 months
Percentage of participants achieving CDAI LDA (</=10)
Time Frame: From baseline to 6 months
From baseline to 6 months
Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period
Time Frame: Baseline, Month 6
Baseline, Month 6
Percentage of participants for whom non-biologic DMARDs was added during observation period
Time Frame: From baseline to 6 months
From baseline to 6 months
Percentage of participants with dose change in biological treatment during study
Time Frame: From baseline to 6 months
From baseline to 6 months
Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study
Time Frame: From baseline to 6 months
From baseline to 6 months
Percentage of participants who started or stopped oral corticosteroid treatment during the study period
Time Frame: From baseline to 6 months
From baseline to 6 months
Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study
Time Frame: From baseline to 6 months
From baseline to 6 months
Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline
Time Frame: From baseline to 6 months
From baseline to 6 months
Cumulated doses of oral corticosteroids during study period
Time Frame: From baseline to 6 months
From baseline to 6 months
Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections
Time Frame: From baseline to 6 months
From baseline to 6 months
Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections
Time Frame: From baseline to 6 months
From baseline to 6 months
Cumulated doses of all corticosteroids during study period
Time Frame: From baseline to 6 months
From baseline to 6 months
Mean dose of corticosteroids at start and end of study
Time Frame: From baseline to 6 months
From baseline to 6 months
Mean change from baseline to end of study of corticosteroids
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in crohns disease activity index (CDAI) score
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in swollen 28 joint count
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in tender 28 joint count
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale)
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale)
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI)
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in Severity of pain (VAS scale)
Time Frame: Baseline, Month 6
Baseline, Month 6
Mean change from baseline to end of study in EULAR response
Time Frame: Baseline, Month 6
Baseline, Month 6
Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6)
Time Frame: From baseline to 6 months
From baseline to 6 months
Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2)
Time Frame: From baseline to 6 months
From baseline to 6 months

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.
March 24, 2016

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.
December 7, 2017

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.
December 7, 2017

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).
February 8, 2016

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.
February 8, 2016

First Posted (ESTIMATE)

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.
February 10, 2016

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.
July 26, 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.
July 24, 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.
July 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.
  • ML29933

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.

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