Stydy to evaluate the efficacy and security of anakinra for the treatment of unresponsiveness arthritis to conventional treatment in systemic lupus erythematosus

• Register: EUCTR
• Last refreshed on: 19 April 2022
• Main ID: EUCTR2011-005392-16-ES
• Date of registration: 17/04/2012
• Prospective Registration: Yes
• Primary sponsor: Dr Josep Ordi Ros
• Public title: Stydy to evaluate the efficacy and security of anakinra for the treatment of unresponsiveness arthritis to conventional treatment in systemic lupus erythematosus
• Scientific title: Study to evaluate the efficacy and safety of Anakinra in the treatment of articular manifestations refractory to conventional therapy in Systemic Lupus Erythematosus patients - ANAKINRA AND LUPUS ARTHRITIS
• Date of first enrolment: 23/05/2012
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005392-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; 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): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: UNIDAD ENFERMEDADES SISTEMICAS
• Affiliation: HOSPITAL UNIVERSITARI VALL D'HEBRON

• Name: UNIDAD ENFERMEDADES SISTEMICAS
• Affiliation: HOSPITAL UNIVERSITARI VALL D'HEBRON

Key inclusion & exclusion criteria

Inclusion criteria:
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 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:


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

Health Condition(s) or Problem(s) studied

Systemic lupus erythematosus
MedDRA version: 14.1 Level: PT Classification code 10042945 Term: Systemic lupus erythematosus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

Trade Name: KINERET
Product Name: KINERET
Product Code: KINERET
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: ANAKINRA
CAS Number: 143090-92-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s):

Secondary Objective:

Main Objective:

Secondary ID(s)

ORDI-03

Source(s) of Monetary Support

health department

Ethics review

Status: Approved
Approval date: 16/01/2012
Contact:

Results

• Results available: Yes
• Date Posted: 27/11/2021
• Date Completed: 31/01/2013
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2011-005392-16/results