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.

Rheumatoid Arthritis (RA) Clinical Trial

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01835613
• Other study ID #: AR/BIOM
• Status: Recruiting
• Phase: Phase 4
• First received: April 1, 2013
• Last updated: April 18, 2013
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: April 2013
• Source: Osservatorio Epidemiologico GISEA
• Contact: Giovanni Lapadula, Prof.
• Phone: +39 080 5478866
• Email: info[@]oegisea.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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).

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis (RA)

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Italy	Università Cattolica del Sacro Cuore	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Osservatorio Epidemiologico GISEA

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Activity Score (DAS-44)		12 months	No
Secondary	Simplified Disease Activity Index (SDAI);Biomarkers Measures		SDAI at 3-6-12-18 months	No
Secondary	Biomarkers Measures	Evaluation by ELISA of the levels of the following biomarkers: IL-8, MCP-1, Chemerin, IL-1a, IL-1ß, IL-17, IL-23, TGFß1, IL-10, BAFF.in the plasma:	Biomarkers Measures at 3-6-12-18 months	No