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.

Osservatorio Epidemiologico GISEA

Status and phase: Unknown; Phase 4

Conditions: Rheumatoid Arthritis (RA)

Treatments: Other: Biomarkers Measures

Study type: Interventional

Funder types: Other

Identifiers

NCT01835613

AR/BIOM

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Tocilizumab

Other group

Description:

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.

Treatment:

Other: Biomarkers Measures