rheumatoid arthritis
Conditions
Interventions
Product Name: 99mTc-S-HYNIC Certolizumab pegol
Pharmaceutical Form: Solution for injection
INN or Proposed INN: CERTOLIZUMAB PEGOL
CAS Number: 428863-50-7
Concentration unit: mg milligram(s)
Concentra
Sponsors
Ghent University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age between 18 and 70 years with presence of documented diagnosis (clinical evaluation, x-ray hands and feet = 3 months before inclusion) of rheumatoid arthritis (RA) at least 3 months and no longer than 15 years defined according to the ACR/EULAR criteria 2010. • It should be a RA who has an inadequate response to at least 2 DMARDs of which one is methotrexate. Methotrexate should be started at least 3 months before baseline and the dosage and route of administration should be stable for at least 2 months before baseline. The minimal weekly doses allowed for methotrexate is 10 mg and the maximal dose is 25 mg. • Conform with the Belgian reimbursement criteria for anti-TNF therapy, the DAS28 should be > 3.7. • Patients should have failed one, but maximum two anti-TNFa treatments other than Cimzia®. • Active disease according to the rheumatologist with DAS28 score =3.7 and at least 1 swollen joint clinically on a 66-swollen joint count. 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 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: • The patients may not have received any experimental biological and/or non-biological therapy in the last 3 months or 5 times the half-life of the therapy before baseline. • The patients may not have received a treatment with certolizumab pegol and/or abatacept and/or tocilizumab and/or rituximab. • Known hypersensitivity to certolizumab pegol ,abatacept or tocilizumab or one of its excipients. • Current or recent history of severe progressive uncontrolled renal, hepatic, hematological, gastro-intestinal, endocrinal, pulmonal, cardial, neurological or cerebral disorders. • Severe or life-threatening infection in the last 6 months; signs and symptoms of a current or recent infection. • Actieve tuberculosis. • Latent tuberculosis, with the exception of patient who are adequately treated according to the local regulations. Absence of latent tuberculosis is defined as a negative tuberculine skintest (Mantoux PPD test) and a recent (< 6 months) x-ray of thorax which shown no suggestive injuries for TB. • Known or current viral hepatitis B or hepatitis C infection. Known HIV infection. • Presence of malignity or history of a maligne pathology. • History of lymphoproliferatic disorder or signs or symptoms suggestive for such a disorder. • Moderate to severe cardiac failure (NYHA-class III/IV). • Women of childbearing potential and who are not taking adequate contraception (such as oral/parenteral/implantable hormonal therapy, intra-uterine device, or barrier and spermicide method). Patient should agree to use adequate contraception during the study and until 12 weeks after the last administration of certolizumab pegol, abatacept or tocilizumab.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate a treatment decision algorithm based upon ‘in vivo’ demonstration of TNFa by using a radiolabeled scintigraphic procedure with Technetium-labeled Cimzia®. To demonstrate that Cimzia® has a larger effect than alternative therapies (Orencia®/Roactemra®) in scintigraphy positive patients as compared to scintigraphy negative patients. Thus, we want to show that there is an interaction between the scintigraphic result and the treatment. ;Secondary Objective: A secondary objective is to show superiority of Cimzia® in the scintigraphy positive patients. ;Primary end point(s): Demonstration of significant ‘in vivo’ TNFa expression would predict a good response to the ‘TNFa Class Switch’-option, whereas absence of demonstrable TNFa would result in a better response to a biological with another mode of action.;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Belgium
Contacts
Public ContactBimetra Clinics
Ghent University Hospital
Outcome results
None listed