Rheumatoid arthritis (RA) MedDRA version: 17.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Cimzia
Pharmaceutical Form: Injection
Trade Name: Orencia
Pharmaceutical Form: Solution for infusion in pre-filled syringe
Trade Name: RoActemra
Pharmaceutical Form: Infusion
Trade Name
Sponsors
The Karolinska Institutet, ClinTRID
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
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: a. Successfully treated cutaneous squamous cell or basal cell carcinoma b. Localized carcinoma in situ of the cervix c. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess and compare de-escalation strategies in patients who respond to first-line therapy in the NORD-STAR study and have reached low disease activity (2.8 < CDAI = 10.0).;Secondary Objective: Safety.;Primary end point(s): The primary efficacy outcome is 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.;Timepoint(s) of evaluation of this end point: 24 weeks after the dose was first reduced. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The proportion of patients who maintain low disease activity (2.8 < CDAI = 10.0) 24 weeks after randomization, patients with early dose reduction vs patients where dose reduction has not been started. 2. The portion of patients in the 4 different treatment arms (active conventional- vs certolizumab-pegol- vs abatacept- vs tocilizumab -treatments) who maintain low disease activity at 24 weeks after a) dose reduction (compare primary outcome) and b) randomization (compare first secondary outcome). This to identify which treatment has the highest likelihood of inducing a sustained state of low disease activity according to CDAI: 3. Clinical (at all relevant time points) outcomes for patients in this study vs. patients who reached remission and were studied in treatment part 2 in the NORD-STAR study: a. CDAI/SDAI/2010 ACR/EULAR low disease activity at all time points b. ACR20/ACR50/ACR70/ACR-hybrid c. DAS28-ESR - values - DAS28-ESR based disease categories - EULAR responses d. DAS28-CRP - values - DAS28-CRP based disease categories - EULAR responses e. SDAI, CDAI values f. Core set variables (66/68 joint count) g. FACIT fatigue score h. WPAI i. EQ5D j. HAQ k. SF36 l. Morning stiffness m. Patient’s VAS for global health, pain and fatigue assessment n. Physician’s VAS for global health;Timepoint(s) of evaluation of this end point: 1. 24 weeks after randomization for all patients 2. a) 24 weeks after the dose was first reduced. b) 24 weeks after randomization for all patients 3. Clinical outcomes are relevant at all time points throughout the study | — |
Countries
Sweden
Contacts
Public ContactCentral Study Coordinating Team
The Karolinska Institute
Outcome results
None listed