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Trial record 45 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity

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ClinicalTrials.gov Identifier: NCT02466581
Recruitment Status : Recruiting
First Posted : June 9, 2015
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
Ronald van Vollenhoven, prof., Karolinska Institutet

Tracking Information
First Submitted Date  ICMJE May 29, 2015
First Posted Date  ICMJE June 9, 2015
Last Update Posted Date December 4, 2018
Study Start Date  ICMJE February 2015
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
Proportion of patients maintaining low disease activity after dose reduction [ Time Frame: 24 weeks 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02466581 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dose Reduction for Early Rheumatoid Arthritis Patients With Low Disease Activity
Official Title  ICMJE 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
Brief 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). 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.
Detailed Description There are currently 23 patients included in the study of which 1 has had an early termination an 17 have terminated the full study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • Drug: Sulphasalazine + Hydroxychloroquine 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)
    Other Name: SSZ+HCQ or Prednisolone
  • Biological: Cimzia
    Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week
    Other Name: Certolizumab-pegol
  • Biological: Orencia
    Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week
    Other Name: Abatacept
  • Biological: RoActemra
    Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week. Methotrexate: 25mg/week
    Other Name: Tocilizumab
Study Arms  ICMJE
  • Active Comparator: Arm 1

    Patients 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.

    Interventions:
    • Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone
    • Biological: Cimzia
    • Biological: Orencia
    • Biological: RoActemra
  • Active Comparator: Arm 2

    Patients 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.

    Interventions:
    • Drug: Sulphasalazine + Hydroxychloroquine OR Prednisolone
    • Biological: Cimzia
    • Biological: Orencia
    • Biological: RoActemra
Publications * Glinatsi D, Heiberg MS, Rudin A, Nordström D, Haavardsholm EA, Gudbjornsson B, Østergaard M, Uhlig T, Grondal G, Hørslev-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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2015)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 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).
  2. 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.
  3. Subject has not more than 3 tender out of the 28 joints.
  4. According to the investigators opinion the remaining findings are not due to significant active disease (RA).
  5. 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)
    • Contraceptives (oral, parenteral, patch) for three months prior to study drug administration)
    • A vasectomized partner
  6. Subject is judged to be in good general health as determined by the principal investigator.
  7. Subject must be able and willing to provide written informed consent and comply with the requirements of this study protocol.

Exclusion Criteria:

  1. Subject has left the NORD-STAR study due to moderate or high disease activity (CDAI ≥ 10.0) or for other medically important event(s).
  2. Patient is eligible for treatment part 2 (A or B) in the NORD-STAR study.
  3. 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.
  4. 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.
  5. Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis).
  6. Subject has history of neurologic symptoms suggestive of central nervous system (CNS) demyelinating disease and/or diagnosis of central demyelinating disease.
  7. Subject has history of cancer or lymphoproliferative disease. Allowable exceptions:

    1. Successfully treated cutaneous squamous cell or basal cell carcinoma
    2. Localized carcinoma in situ of the cervix
    3. Curatively treated malignancy (treatment terminated) > 5 years prior to randomization.
  8. 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.
  9. 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.
  10. Men who are planning to father a child during the time they are included in the study.
  11. Subject has a history of clinically significant drug or alcohol usage in the last year.
  12. Subject has a chronic widespread pain syndrome.
  13. Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
  14. Subject is unwilling to comply with the study protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ronald van Vollenhoven, MD, Prof. +46(0)851776077 ronald.van.vollenhoven@ki.se
Contact: Johanna Estelius, PhD +46(0)851771110 johanna.estelius@ki.se
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02466581
Other Study ID Numbers  ICMJE CO-STAR
2014-002374-36 ( EudraCT Number )
2014/1705-31/3 ( Other Identifier: Regional Ethical Review Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ronald van Vollenhoven, prof., Karolinska Institutet
Study Sponsor  ICMJE Karolinska Institutet
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Karolinska Institutet
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP