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Rheumatoid ArthritisNCT02679001

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.

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 11 sites in Sweden.

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 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. 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?
TNF inhibitor/TCZ
How many people
200 participants
Where
11 sitesSweden
Study dates
24 Mar 2016to 7 Dec 2017
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

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.

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

Sweden11 sites

  • Arvika Sjukhus; Reumatologimottagningen - Medicinmottagningen

    Arvika, 671 80

  • Mälarsjukhuset; Reumatologkliniken

    Eskilstuna, 631 88

  • Karolinska University Hospital, Huddinge; Rheumatology

    Huddinge, SE-141 86

  • Blekingesjukhuset Karlskrona; Medicin, Rheumatology

    Karlskrona, 37185

  • Skånes Universitetssjukhus Malmö; Reumatologkliniken

    Malmö, 205 02

  • Capio Citykliniken, Reumatologen

    Malmö, 212 28

  • Örebro Uni Hospital; Rheumatology

    Örebro, 70185

  • Kaernsjukhuset; Dept of Medicine

    Skövde, 54185

  • Danderyds Sjukhus Ab; Rheumatology

    Stockholm, 18288

  • Lasarettet Trelleborg;Reumatologmottagningen

    Trelleborg, 231 85

  • Akademiska sjukhuset, Reumatologkliniken

    Uppsala, 75185

Other trials in Sweden

About this study

Official title: 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.

Being tested
TNF inhibitor/TCZ
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • TNF inhibitor/TCZDrug

    Also called COTTON

    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.

Study groups in NCT02679001
Study groupRoleWhat they receive
RA participants treated with a TNF inhibitor or TCZParticipants 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.
Receives: Drug: TNF inhibitor/TCZ

What is being measured

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

  1. Percentage of participants with a decrease in dose of oral corticosteroids during the study

    Measured: From baseline to 6 months

Secondary outcomes (27)

  1. Percentage of participants achieving C59CDAI remission (</=2.8)

    Measured: From baseline to 6 months

  2. Percentage of participants achieving CDAI LDA (</=10)

    Measured: From baseline to 6 months

  3. Percentage of participants using non-biologic disease-modifying anti-rheumatic drugs (C58MARDs) at treatment initiation and at the end of observation period

    Measured: Baseline, Month 6

  4. Percentage of participants for whom non-biologic DMARDs was added during observation period

    Measured: From baseline to 6 months

  5. Percentage of participants with dose change in biological treatment during study

    Measured: From baseline to 6 months

  6. Percentage of participants with use of oral corticosteroids at treatment initiation and at end of study

    Measured: From baseline to 6 months

  7. Percentage of participants who started or stopped oral corticosteroid treatment during the study period

    Measured: From baseline to 6 months

  8. Percentage of participants with increased/decreased/stable dose of corticosteroids from baseline to end of study

    Measured: From baseline to 6 months

  9. Percentage of participants with change in dose of corticosteroids during study but with same dose at study end as at baseline

    Measured: From baseline to 6 months

  10. Cumulated doses of oral corticosteroids during study period

    Measured: From baseline to 6 months

  11. Number of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections

    Measured: From baseline to 6 months

  12. Cumulated doses of corticosteroids including but not limited to intra-articular, intravenously, inhaled, topical and/or intramuscular/subcutaneous injections

    Measured: From baseline to 6 months

  13. Cumulated doses of all corticosteroids during study period

    Measured: From baseline to 6 months

  14. Mean dose of corticosteroids at start and end of study

    Measured: From baseline to 6 months

  15. Mean change from baseline to end of study of corticosteroids

    Measured: Baseline, Month 6

  16. Mean change from baseline to end of study in DAS28 (sedimentation rate [SR]) score

    Measured: Baseline, Month 6

  17. Mean change from baseline to end of study in DAS28 (C-Reactive Protein [CRP]) score

    Measured: Baseline, Month 6

  18. Mean change from baseline to end of study in crohns disease activity index (CDAI) score

    Measured: Baseline, Month 6

  19. Mean change from baseline to end of study in swollen 28 joint count

    Measured: Baseline, Month 6

  20. Mean change from baseline to end of study in tender 28 joint count

    Measured: Baseline, Month 6

  21. Mean change from baseline to end of study in Physician Global Assessment of disease activity (Visual Analogue Scale [VAS] scale)

    Measured: Baseline, Month 6

  22. Mean change from baseline to end of study in Patient Global Assessment of disease activity (VAS scale)

    Measured: Baseline, Month 6

  23. Mean change from baseline to end of study in Health Assessment Questionnaire Disability Index (HAQ-DI)

    Measured: Baseline, Month 6

  24. Mean change from baseline to end of study in Severity of pain (VAS scale)

    Measured: Baseline, Month 6

  25. Mean change from baseline to end of study in EULAR response

    Measured: Baseline, Month 6

  26. Percentage of participants achieving DAS28 remission (less than or equal to [</=] 2.6)

    Measured: From baseline to 6 months

  27. Percentage of participants achieving DAS 28 Low Disease Activity (LDA) (</=3.2)

    Measured: From baseline to 6 months

Timeline

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

  1. First posted10 Feb 2016 (estimated)
  2. Study start24 Mar 2016
  3. Primary completion7 Dec 2017
  4. Study completion7 Dec 2017

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
Other
Time perspective
Cross-sectional
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02679001
Sponsor's protocol ID
ML29933
Status last verified
Jul 2018
First submitted
8 Feb 2016
Last updated
26 Jul 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis, run by Hoffmann-La Roche at 11 sites in Sweden.

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 5 inclusion and 3 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 26 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Sweden. 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?

Percentage of participants with a decrease in dose of oral corticosteroids during the study (time frame: From baseline to 6 months). 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 NCT02679001.

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 26 Jul 2018.

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Clinical Trial NCT02679001 | AzTrials