Recruitment

Recruitment Status
Completed

Summary

Conditions
Rheumatoid Arthritis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Min Age
18
Max Age
125
Gender
Both

Description

Randomized double-blinded controlled multi-centre, study over 12 weeks, followed by a 12 weeks single blinded multicenter trial in 156 patients with RA with inadequate response to DMARD therapy. The study is composed of 3 arms with a 1:1:1 randomization at baseline: High functional MRI/400mg Certoli...

Randomized double-blinded controlled multi-centre, study over 12 weeks, followed by a 12 weeks single blinded multicenter trial in 156 patients with RA with inadequate response to DMARD therapy. The study is composed of 3 arms with a 1:1:1 randomization at baseline: High functional MRI/400mg Certolizumab Pegol on week 0,2 and 4 followed by Certolizumab Pegol 200mg every two weeks for a total of 24 weeks; low functional MRI/400mg Certolizumab Pegol on week 0,2 and 4 followed by Certolizumab Pegol 200mg every two weeks for a total of 24 weeks with the possibility of early escape at week 12. Patients who did not respond sufficiently according to EULAR response criteria (DAS28 reduction ≥ 1.2) to Certolizumab-Pegol (Treatment Arm A and Arm B) after 12 weeks will be off-Study and treated according to local guidelines. Patients in the Placebo group with an EULAR response ≥ 1.2 reaching remission (DAS28 ≤ 2.6) will also be off study and treated according to the local guidelines or will be followed while they are in clinical remission. Patients with an EULAR response (DAS28 reduction ≥ 1.2) but not fulfilling the clinical remission criteria (DAS28 ≤ 2.6) will receive Certolizumab Pegol in week 12,14 and 16 with Certolizumab Pegol 400mg s.c. followed by s.c.injection of 200mg Certolizumab Pegol every two weeks till week 24. In the situation that in one group sufficient patients will be randomized, fMRI done at screening, needs to be analyzed first to ensure that no further patient will be randomized with the randomization to the closed group. A blinded person, not involved either in the analysation of the fMRI nor in the treatment of the patients or the clinical assessments, will be responsible for the randomization list. If the next number on the randomization list represent the number of the closed group, the patient is not eligible for the study and will be treated according to local guidelines.

Locations

Leipzig, 04103
Berlin, 10117
Erlangen, 91054
Freiburg, 79106
Belgrad, 11000
...
Leipzig, 04103
Berlin, 10117
Erlangen, 91054
Freiburg, 79106
Belgrad, 11000
Coimbra, 3000-075

Tracking Information

NCT #
NCT01864265
Collaborators
Not Provided
Investigators
  • Principal Investigator: Juergen Rech, MD University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology Study Director: Georg Schett, MD, Prof. University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology
  • Juergen Rech, MD University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology Study Director: Georg Schett, MD, Prof. University of Erlangen-Nuremberg, Department of Internal Medicine 3, Rheumatology & Immunology