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.

NCT ID: NCT01835613

Last Updated: 2013-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-12-31

Brief Summary

The purpose of this study is to assess the clinical response to IL-6 inhibition defined as Low Disease Activity (DAS44) <2.4) at the follow-up visit at 12 months and the correlation between the biomarkers and treatment response.

Conditions

Rheumatoid Arthritis (RA)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tocilizumab

Biomarkers Measures

At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers.

Group Type: OTHER

Biomarkers Measures

Intervention Type: OTHER

At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers.

Interventions

Biomarkers Measures

At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Signed informed consent form;
• Patients aged 18 - 75 years;
• RA classified in compliance with the 2010 ACR/EULAR criteria;
• Patients that have to suspend a previous treatment with DMARDs for total ineffectiveness or intolerance to drugs and/or patients that have not responded adequately to first-line combination DMARDs / biological treatment;
• Patients for which is indicated to start a treatment with an inhibitor of IL-6R for high values indicative of systemic inflammation (ESR>=28 mm/hour, 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 DMARDs use which make it necessary to take biological drug in monotherapy.
• Corticosteroids therapy stable (< = 7.5 mg)for at least four weeks;
• Joint symptoms for at least three but no more than 24 months from the screening visit;
• DAS44 >2.4 and/or SDAI >11
• Willing and able to comply with study procedures and timing.

Exclusion Criteria

• On going pregnancy or lactation;
• Severe active infections;
• Patients with other clinically significant concomitant diseases whose treatment or outcome could interfere with the expected evaluations of the study protocol.
• Blood AST or ALT levels >5 times the upper normal limit;
• ANC count <0.5 x 109/L
• Platelet count <50 x103 /μL
• Patients with other autoimmune rheumatic diseases, in addition to AR (for example systemic lupus erythematosus [SLE], scleroderma, polymyositis, ecc…)
• Medical history or concomitant joint diseases in additions to AR (for example tophaceous gout, reactive arthritis, psoriatic arthritis).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osservatorio Epidemiologico GISEA

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gianfranco Ferraccioli, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma

Locations

Università Cattolica del Sacro Cuore

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Giovanni Lapadula, Prof.

Role: CONTACT

info@oegisea.it

+39 080 5478866

Other Identifiers

AR/BIOM

Identifier Type: -

Identifier Source: org_study_id