Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).

• Register: EUCTR
• Last refreshed on: 20 August 2018
• Main ID: EUCTR2016-004300-65-BE
• Date of registration: 20/01/2017
• Prospective Registration: Yes
• Primary sponsor: Ghent University Hospital
• Public title: Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®).
• Scientific title: Optimizing the Biologic Treatment Strategy in Rheumatoid Arthritis (RA) Patients that have failed a Tumor Necrosis Factor-alpha (TNFa) blocking Agent by immunoscintigraphy with Technetium-labeled Cimzia®). - SCINTRA TRIS
• Date of first enrolment: 26/09/2017
• Target sample size: 120
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004300-65
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Belgium

Contacts

• Name: Bimetra Clinics
• Affiliation: Ghent University Hospital

• Name: Bimetra Clinics
• Affiliation: Ghent University Hospital

Key inclusion & exclusion 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:
• 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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

rheumatoid arthritis

Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Intervention(s)

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)
Concentration type: equal
Concentration number: 1.25-

Primary Outcome(s)

Timepoint(s) of evaluation of this end point: 24 weeks

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.

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.

Secondary Objective: A secondary objective is to show superiority of Cimzia® in the scintigraphy positive patients.

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: None

Secondary end point(s): None

Secondary ID(s)

AGO/2016/012

Source(s) of Monetary Support

UCB Pharma SA