Active Conventional Therapy Compared to Three Different Biologic Treatments in Early Rheumatoid Arthritis With Subsequent Dose Reduction
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01491815|
Recruitment Status : Active, not recruiting
First Posted : December 14, 2011
Last Update Posted : July 8, 2022
This is an international (Sweden, Finland, Norway, Denmark, Iceland and the Netherlands) trial designed to compare the safety and efficacy of active conventional therapy (ACT) and three biologic treatments in subjects with early rheumatoid arthritis (RA). The global aim of this study is to assess and compare
- the proportion of subjects who achieve remission with ACT versus three different biologic therapies (Certolizumab-pegol, Abatacept or Tocilizumab)
- two alternative de-escalation strategies in patients who respond to first-line therapy.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Drug: Non-biological DMARD's Biological: Cimzia Biological: Orencia Biological: RoActemra||Phase 4|
After completed enrollment a total of 812 patients were included in the study.
371 of the included patients have entered treatment part 2, 256 patients have exited the study after treatment part 1, 207 patients have had early termination and 322 patients have completed the full study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||812 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Multicenter, Randomized, Open-label, Blinded-assessor, Phase 4 Study in Patients With Early Rheumatoid Arthritis to Compare Active Conventional Therapy Versus Three Biologic Treatments, and Two De-escalation Strategies in Patients Who Respond to Treatment|
|Actual Study Start Date :||December 14, 2012|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||December 2023|
Active Comparator: Active conventional therapy (ACT)
Non-biological DMARD's: Methotrexate plus steroids or Methotrexate plus Sulphasalazine and Hydroxychloroquine and steroids
Drug: Non-biological DMARD's
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, Iceland, and the Netherlands)
Active Comparator: Biologic agent 1
Cimzia: Certolizumab-pegol plus Methotrexate and steroids
Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week
Active Comparator: Biologic agent 2
Orencia: Abatacept plus Methotrexate and steroids
Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week
Active Comparator: Biologic agent 3
RoActemra: Tocilizumab plus Methotrexate and steroids
Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week.
- The proportion of patients in remission at week 24 from baseline according to CDAI [ Time Frame: 24 weeks from BL ]Treatment Part 1: The primary efficacy outcome is the proportion of patients in remission at week 24 from BL according to CDAI
- The proportion of patients in remission at week 24 after dose-reduction according to CDAI [ Time Frame: 24 weeks after dose-reduction ]Treatment Part 2: The primary efficacy outcome is the proportion of patients in remission according to CDAI, at the time point 24 weeks after the dose was first reduced
- The radiographic progression of total Sharp van der Heijde score after 48 weeks from baseline [ Time Frame: 48 weeks from BL ]The primary efficacy outcome is the progression of total Sharp van der Heijde score after 48 weeks from BL
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491815
|Principal Investigator:||Ronald van Vollenhoven, MD, Prof.||The Karolinska Institute|