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.

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01835613

Enrollment

150

Registered

2013-04-19

Start date

2013-01-31

Completion date

2015-12-31

Last updated

2013-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid Arthritis, Early RA, RA, IL-6, IL-6R, Inhibitor, Inhibition, Tocilizumab, Biomarkers, DMARDs, Biological, DAS, SDAI, AR/BIOM, OEG

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.

Interventions

OTHERBiomarkers 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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).

Design outcomes

Primary

Measure	Time frame
Disease Activity Score (DAS-44)	12 months

Secondary

Measure	Time frame	Description
Simplified Disease Activity Index (SDAI);Biomarkers Measures	SDAI at 3-6-12-18 months	—
Biomarkers Measures	Biomarkers Measures at 3-6-12-18 months	Evaluation by ELISA of the levels of the following biomarkers: IL-8, MCP-1, Chemerin, IL-1α, IL-1β, IL-17, IL-23, TGFβ1, IL-10, BAFF.in the plasma:

Countries

Italy

Contacts

Primary ContactGiovanni Lapadula, Prof.

info@oegisea.it+39 080 5478866

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026