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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 16 October 2017
Main ID:  EUCTR2017-000947-41-FR
Date of registration: 21/06/2017
Prospective Registration: Yes
Primary sponsor: Groupement des Hôpitaux de l’Institut Catholique de Lille
Public title: ORENCIA VERSUS ROACTEMRA BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS.
Scientific title: ABATACEPT VERSUS TOCILIZUMAB BY SUBCUTANEOUS ADMINISTRATION FOR THE TREATMENT OF RHEUMATOID ARTHRITIS IN TNF ALPHA INHIBITOR INADEQUATE RESPONDER PATIENTS: A RANDOMIZED, OPEN-LABELED, SUPERIORITY TRIAL. - SUNSTAR
Date of first enrolment: 18/08/2017
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2017-000947-41
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
France
Contacts
Name: Promotion CRA   
Address:  Département de le Recherche Médicale - Hôpital Saint-Philibert, 115 rue du Grand But 54962 Lomme France
Telephone: 330320225751
Email: vitagliano.jean-jacques@ghicl.net
Affiliation:  Groupement des Hôpitaux de l’Institut Catholique de Lille
Name: Promotion CRA   
Address:  Département de le Recherche Médicale - Hôpital Saint-Philibert, 115 rue du Grand But 54962 Lomme France
Telephone: 330320225751
Email: vitagliano.jean-jacques@ghicl.net
Affiliation:  Groupement des Hôpitaux de l’Institut Catholique de Lille
Key inclusion & exclusion criteria
Inclusion criteria:
- age >18 years
- RA according to the ACR/EULAR 2010 criteria
- inadequate response to a subcutaneously administered first-line TNFi defined as moderate to high disease activity (DAS28-ESR>3.2 and CDAI>10) after at least 3 months of treatment with a TNFi
- beneficiary of the French National Health Insurance Fund
- signed informed consent form
- for women of childbearing age: effective contraception during treatment period with engagement to continue such contraception for 14 weeks after last administration

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 180
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 44

Exclusion criteria:
- counter-indication for one or other of the two drugs under study
- Patient receiving a cortisteroid therapy over 15mg/day prednison equivalent for more than 4 weeks
- failure of the TNFi for intolerance
- breastfeeding woman



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Adults patients suffering from rheumatoid arthritis and in adequate response to a first line of treatment with a TNF alpha inhibitor.
MedDRA version: 20.0 Level: HLT Classification code 10039075 Term: Rheumatoid arthritis and associated conditions System Organ Class: 100000004870
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Intervention(s)

Trade Name: ORENCIA 125 mg, solution injectable en seringue préremplie
Pharmaceutical Form: Solution for injection/infusion in pre-filled syringe

Trade Name: RoActemra 162 mg solution injectable en seringue préremplie
Pharmaceutical Form: Solution for injection

Primary Outcome(s)
Main Objective: Compare tocilizumab versus abatacep administered subcutaneously efficacy in inadequate responder patients to a first-line biologic regimen with a TNFi.
Primary end point(s): Evolution of the Clinical Disease Activity Index (CDAI) at 6 months.
The CDAI is a composite score combining clinical items only: Tender 28-joint count, Swollen 28-joint count, Patient Global Disease Activity (PGA), Evaluator’s Global Disease Activity (EGA). This score provides a numerical assessment reflecting disease activity independently of acute phase reactants. It is well known that acute phase reactants (erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) levels) exhibit clear improvement with tocilizumab, better than with other treatments, but not necessarily with an associated clinical significance.
Secondary Objective: 1/ Compare disease progression
2/ Compare treatments response and tolerance
3/ Evaluate radiobiological criteria to provide pathophysiological explanations to differential responses between drugs.
Timepoint(s) of evaluation of this end point: At inlusion , 3, 6 and 12 months
Secondary Outcome(s)
Secondary end point(s): 1/ Secondary outcomes will assess treatment response. Comparisons will be made between the baseline level (M0) and the level observed at 3, 6 and 12 months for :
- DAS28-ESR and DAS28-CRP
- SDAI :
- HAQ, SF-36 FLARE-RA quality of life score
- PGA and EGA VAS
- CDAI and DAS28-ESR LDA (low disease activity)
- Proportion of patients achieving good or moderate European League Against Rheumatism (EULAR) therapeutic response (DS28-ESR)
- Proportion of patients achieving ACR20, ACR50, and ACR70 responses
- Rates of treatment persistence
and at 3 and 12 months :
- CDAI

2/ Tolerance observed at 3, 6 and 12 months
- Proportion of patients presenting at least one side effect, according to NCI-CTCAE v4.0 scale: (Platelets, AST/ALT, Triglycerides, Neutropenia)
- Rates of treatment withdrawals for intolerance
- Rates of treatment withdrawals for intolerance requiring in-hospital care
- Rate of rescue medication use authorized by the protocol and treatment dose

3/ Radiobiological criteria for a better understanding of pathophysiological phenomena:
- changes in joint US-Doppler synovitis and Doppler hyperemia grade of the hands and wrists at 6 months
- changes in Sharp score of hands, wrists and feets radiographs at 12 months
- change in Vascular Endothelial Growth Factor (VEGF) levels at 3 and 6 months
- changes in interleukin-6 serum levels at 6 months
Timepoint(s) of evaluation of this end point: At inlusion , 3, 6 and 12 months
Secondary ID(s)
RC-P0055
Source(s) of Monetary Support
French Ministry of Research
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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