Patients with an active spondyloarthropathy and with an active rheumatoid arthritis
Conditions
Interventions
Trade Name: Cimzia 200 mg solution for injection
Product Name: Certolizumab pegol
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - age between 18 and 70 years old - diagnosed with rheumatoid arthrosis according to the ACR-criteria, OR diagnosed with axial spondyloarthropathy according to the ASAS criteria (of which 5 of them should meet the modified New York criteria), OR diagnosed with peripheral spondylarthropathy - no active tuberculosis - no pregnant women or women who are not using contraceptives when applicable - patients need to understand the study and give informed consent OR diagnosed with erosive hand OA OR diagnosed with active Crohn's disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: - no experimental (non-) biological therapy in the last 3 months, or within 5 halflives befor baseline visit - no anti-TNF therapy - no rituximab and/or abatacept - known hypersensitivity vs certolizumab pegol or one of his components - medical history of serious progressive uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebreal diseases - serious or life-threatening infections over the last 6 months, or signs of current or recent infection - active or latent tuberculosis - known previous or current viral hepatitis B or C - known HIV infection - presence of malignity or history of maligne pathology - History or signs of lyph-proliferative condition - mild to serious cardiac failure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the safety and efficacy of Cimzia, when administered to patients with active rheumatoid arthritis, spondyloarthropathy or Crohn's disease.; Secondary Objective: - To map the biodistribution of TNF-a by administering a radioactive labeled TNFa-blokker (Cimzia, labeled with 99 Technetium) in patients with active rheumatoid arthritis and spondyloarthropathy, and Crohn's disease and erosive hand OA; - To show the correlation between observed sacroilliitis on MRI (golden standard) versus tracer captation in sacroilliacal joints, visualised with SPECT recordings after administration of the labeled Cimzia; - To evaluate whether the used scintigraphy technique (radioactive labeled Certolizumab pegol as tracer) is a predictor for clinical remission, when treated with Cimzia in patients with active rheumatoid arthritis and spondyloarthritis and Crohn's disease. ;Primary end point(s): Patients who are in clinical remission for 2 consecutive major visits, will be discontinued from the study medication.;Timepoint(s) of evaluation of this end point: After 12 weeks, 24 weeks, 36 weeks and 48 weeks of administration of Cimzia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of patients who are going into remission and the duration of remission;Timepoint(s) of evaluation of this end point: After 12 weeks, 24 weeks, 36 weeks and 48 weeks of administration of Cimzia. | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed