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Rheumatoid ArthritisPhase 4NCT02466581

Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity

A Phase 4 study testing Sulphasalazine + Hydroxychloroquine OR Prednisolone, Cimzia and Orencia in people with Rheumatoid Arthritis, run by Karolinska Institutet at 8 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an international (Nordic) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments (Certolizumab-pegol, Abatacept or Tocilizumab) in subjects with early rheumatoid arthritis (RA). 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?
Sulphasalazine + Hydroxychloroquine OR Prednisolone, Cimzia and Orencia
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
8 sitesSweden
Study dates
3 Feb 2015to Dec 2023
Phase
Phase 4
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

  • Subject has been enrolled in the NORD-STAR study according to that study inclusion criteria (and did not meet any of the exclusion criteria in that study).
  • Subject has low-disease-activity according to: 2.8 < CDAI ≤ 10.0, from week 56 in the NORD-STAR study, i.e. during 24 weeks before randomization.
  • Subject has not more than 3 tender out of the 28 joints.
  • According to the investigators opinion the remaining findings are not due to significant active disease (RA).
  • Female subject is either not of childbearing potential (postmenopausal, surgically sterile etc.), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
  • Intrauterine device (IUD)
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  • Contraceptives (oral, parenteral, patch) for three months prior to study drug administration)
  • A vasectomized partner
  • Subject is judged to be in good general health as determined by the principal investigator.
  • Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Who cannot join

  • Subject has left the NORD-STAR study due to moderate or high disease activity (CDAI ≥ 10.0) or for other medically important event(s).
  • Patient is eligible for treatment part 2 (A or B) in the NORD-STAR study.
  • Active infection of any kind (excluding fungal infections of nail beds), or any major episode of infection requiring hospitalization within 4 weeks prior to randomization.
  • Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the study.
  • Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis).
  • Subject has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease.
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  • Subject has history of cancer or lymphoproliferative disease. Allowable exceptions:
  • Successfully treated cutaneous squamous cell or basal cell carcinoma
  • Localized carcinoma in situ of the cervix
  • Curatively treated malignancy (treatment terminated) > 5 years prior to randomization.
  • Subject has a history of listeriosis, histoplasmosis, untreated TB, persistent chronic infections, or recent active infections requiring hospitalization or treatment with intravenous (i.v.) anti-infectives within 30 days or oral anti-infectives within 14 days prior to randomization.
  • Female subject who is pregnant or breast-feeding or considering becoming pregnant during the study or within 150 days after the last dose of study medication.
  • Men who are planning to father a child during the time they are included in the study.
  • Subject has a history of clinically significant drug or alcohol usage in the last year.
  • Subject has a chronic widespread pain syndrome.
  • Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  • Subject is unwilling to comply with the study protocol.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Sweden8 sites

  • Sahlgrenska University Hospital

    Gothenburg

  • The Karolinska University Hospital

    Huddinge

  • Linköping University Hospital

    Linköping

  • Skåne University Hospital

    Lund

  • Skåne University Hospital

    Malmö

  • The Karolinska University Hospital

    Solna

  • Karolinska Institutet

    Stockholm, 171 76

  • Academic Specialist Center

    Stockholm

Other trials in Sweden

About this study

Official title: A Multicenter, Randomized, Open-label, Blinded-assessor, Follow-up, Phase 4 Study in Patients With Rheumatoid Arthritis Who Have Completed the Initial Treatment Part in the NORD-STAR Study and Have Reached Stable Low Disease Activity

This is an international (Nordic) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments (Certolizumab-pegol, Abatacept or Tocilizumab) in subjects with early rheumatoid arthritis (RA). The global aim of this study is to assess and compare two alternative de-escalation strategies in patients who achieved low disease activity during first-line therapy in the NORD-STAR study.

Read the detailed description

25 patients have been included in the study of which 1 has had an early termination an 22 have completed the full study.

Being tested
Sulphasalazine + Hydroxychloroquine OR Prednisolone, Cimzia, Orencia, RoActemra
Medical subject headings
Arthritis, Rheumatoid

What participants receive

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

  • Sulphasalazine + Hydroxychloroquine OR PrednisoloneDrug

    Also called SSZ+HCQ or Prednisolone

    Methotrexate: 25mg/week. SSZ: 2 g/day. HCQ: 35 mg/kg/week (Finland and Denmark) Methotrexate: 25mg/week. Prednisolone 20 mg/day tapered in 9 weeks to 5 mg/day, discontinued after 9 months. (Sweden, Norway, and Iceland)

  • CimziaBiological

    Also called Certolizumab-pegol

    Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week

  • OrenciaBiological

    Also called Abatacept

    Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week

  • RoActemraBiological

    Also called Tocilizumab

    Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week. Methotrexate: 25mg/week

Study groups in NCT02466581
Study groupRoleWhat they receive
Arm 1Active comparatorPatients keep the intervention they had in the NORD-STAR-study (NCT01491815), i.e. one of the four below: 1. Sulphasalazine + Hydroxychloroquine OR Prednisolone plus Methotrexate and steroids 2. Cimzia plus Methotrexate and steroids 3. Orencia plus Methotrexate and steroids 4. RoActemra plus Methotrexate and steroids This intervention is de-escalated starting at randomization.
Receives: Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone; Biological: Cimzia; Biological: Orencia; Biological: RoActemra
Arm 2Active comparatorPatients keep the intervention they had in the NORD-STAR-study (NCT01491815), i.e. one of the four below: 1. Sulphasalazine + Hydroxychloroquine OR Prednisolone plus Methotrexate and steroids 2. Cimzia plus Methotrexate and steroids 3. Orencia plus Methotrexate and steroids 4. RoActemra plus Methotrexate and steroids This intervention is de-escalated starting 24 weeks after randomization.
Receives: Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone; Biological: Cimzia; Biological: Orencia; Biological: RoActemra

What is being measured

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

  1. Proportion of patients maintaining low disease activity after dose reduction

    The proportion of patients, with early dose reduction vs late dose reduction, who maintain low disease activity (2.8 < CDAI ≤ 10.0) at the time point 24 weeks after the dose was first reduced.

    Measured: 24 weeks after dose reduction

Timeline

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

  1. First posted9 Jun 2015 (estimated)
  2. Study start3 Feb 2015
  3. Primary completion22 Jul 2023 (estimated)
  4. Study completionDec 2023 (estimated)

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02466581
Sponsor's protocol ID
CO-STAR
Other IDs
2014-002374-36, 2014/1705-31/3, 2014
Status last verified
Jul 2022
First submitted
29 May 2015
Last updated
8 Jul 2022
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Glinatsi D, Heiberg MS, Rudin A, Nordstrom D, Haavardsholm EA, Gudbjornsson B, Ostergaard M, Uhlig T, Grondal G, Horslev-Petersen K, van Vollenhoven R, Hetland ML. Head-to-head comparison of aggressive conventional therapy and three biological treatments and comparison of two de-escalation strategies in patients who respond to treatment: study protocol for a multicenter, randomized, open-label, blinded-assessor, phase 4 study. Trials. 2017 Apr 4;18(1):161. doi: 10.1186/s13063-017-1891-x.

    PubMed 28376912

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Sulphasalazine + Hydroxychloroquine OR Prednisolone, Cimzia and Orencia in people with Rheumatoid Arthritis, run by Karolinska Institutet at 8 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 10 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 8 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Proportion of patients maintaining low disease activity after dose reduction (time frame: 24 weeks after dose reduction). 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 NCT02466581, which also lists 1 linked publication.

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 8 Jul 2022.

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