Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.

• Register: EUCTR
• Last refreshed on: 3 December 2024
• Main ID: EUCTR2012-001760-30-IT
• Date of registration: 25/07/2012
• Prospective Registration: Yes
• Primary sponsor: OSSERVATORIO EPIDEMIOLOGICO GISEA
• Public title: Evaluation effects of treatment with an inhibitor of the receptor of a protein (interleukin-6 IL-6)involved in inflammatory process, on the clinical response and on the changes from baseline in the biomarkers in patients with rheumatoid arthritis (RA)not responding adequately to Disease-modifying antirheumatic drugs (DMARDs) and/or to a first biological agent.
• Scientific title: Evaluation effects of treatment with IL-6R inhibitor on clinical response and biomarkers in patients with rheumatoid arthritis (RA) not responding to DMARDs and/or a first biological agent.
• Date of first enrolment: 05/11/2012
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-001760-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other: Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): yes

Countries of recruitment

Italy

Contacts

• Name: B.U. CRO
• Affiliation: CD Pharma Group S.r.l.

• Name: B.U. CRO
• Affiliation: CD Pharma Group S.r.l.

Key inclusion & exclusion criteria

Inclusion criteria:
1) Written Informed Consent; 2) Patients aged 18-75 years; 3) RA classified using the 2010 ACR/EULAR criteria; 4) Patients who have had to interrupt a previous treatment with DMARDs for total ineffectiveness or intolerance to drugs and / or patients who have not responded adequately to a combination of a first-line combination of DMARD / biological treatment; 5) Patients in whom it is indicated starting a treatment with an inhibitor of IL-6R, for values ??indicative of high systemic inflammation (ESR = 28 mm/h, PCR> 5 mg/l, Fibrinogen> 400 mg/dl and / or albumin <3.5 g/dl)and high disease activity (DAS> 2.4), or contraindications to the use of DMARDs that should take a biologic drug monotherapy;6) Treatment with corticosteroids at a stable dose (=7.5 mg) for at least 4 weeks; 7) Joint symptoms for at least three but no more than 24 months from the screening visit (early RA); 8) DAS44 >2.4 and/or SDAI >11 (moderate or high activity); 9) Patients able to comply with the procedures and timing of the study.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion criteria:
1) Ongoing pregnancy or lactation; 2) Severe active infections; 3) Patients with other clinically significant concomitant diseases, whose treatment and outcome are able to interfere with the evaluation required by the study protocol; 4) Blood AST or ALT > 1.5 times the upper normal limit; 5) ANC count < 2 x 103/µl; 6) Platelet count < 100 x 103/µl; 7) Patients with other autoimmune rheumatic diseases in addition to the RA (eg,systemic lupus erythematosus [SLE], scleroderma, polymyositis, etc ...); 8) Clinical history or presence of other concomitant inflammatory diseases in addition to RA ( tophaceous gout, reactive arthritis, psoriatic arthritis, etc. ...).


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

Health Condition(s) or Problem(s) studied

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

Rheumatoid Arthritis
MedDRA version: 14.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

Intervention(s)

Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Trade Name: RoActemra
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: TOCILIZUMAB
CAS Number: 375823-41-9
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-

Primary Outcome(s)

Primary end point(s): The primary efficacy variables for the study is the Disease Activity Score (DAS-44)at follow-up visit at 12 months.

Main Objective: The primary objective of this study is to evaluate the clinical response to the inhibition of the IL-6R,defined as an achievement of a low disease activity(value of the Disease Activity Score (DAS 44)<2.4) at follow-up visit at 12 months and to correlate it to the biomarkers.

Timepoint(s) of evaluation of this end point: At follow-up visit at 12 months.

Secondary Objective: The secondary objective of the study is to evaluate the correlation between changes from baseline in the biomarkers and in the treatment response, defined as Remission - DAS-44 <1.6 or Simplified Disease Activity Index (ICSD) <3.3, in addition to the DAS of at least 1.2, at all follow-up visits.

Secondary Outcome(s)

Secondary end point(s): The secondary efficacy variables for the study are the following: Disease Activity Score (DAS-44)at all other times, Simplified Disease Activity Index (SDAI) and measurement of the biomarkers at all follow-up visits.

Timepoint(s) of evaluation of this end point: Disease Activity Score (DAS-44)at 3,6,18 months from baseline. Simplified Disease Activity Index (SDAI) and measurement of the biomarkers at 3,6,12 and 18 months from baseline.

Secondary ID(s)

AR/BIOM

Source(s) of Monetary Support

Osservatorio Epidemiologico GISEA

Roche S.p.A.

Ethics review

Status: Approved
Approval date: 19/07/2012
Contact: