Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02466581
Other study ID # CO-STAR
Secondary ID 2014-002374-3620
Status Active, not recruiting
Phase Phase 4
First received
Last updated
Start date February 3, 2015
Est. completion date December 2023

Study information

Verified date July 2022
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


Description:

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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 25
Est. completion date December 2023
Est. primary completion date July 22, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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)
Biological:
Cimzia
Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week
Orencia
Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week
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

Locations

Country Name City State
Sweden Sahlgrenska University Hospital Gothenburg
Sweden The Karolinska University Hospital Huddinge
Sweden Linköping University Hospital Linköping
Sweden Skåne University Hospital Lund
Sweden Skåne University Hospital Malmö
Sweden The Karolinska University Hospital Solna
Sweden Academic Specialist Center Stockholm
Sweden Karolinska Institutet Stockholm

Sponsors (1)

Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 24 weeks after dose reduction
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4