NCT01835613

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2013

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 19, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 19, 2013

Status Verified

April 1, 2013

Enrollment Period

2.5 years

First QC Date

April 1, 2013

Last Update Submit

April 18, 2013

Conditions

Rheumatoid Arthritis (RA)

Keywords

Rheumatoid ArthritisEarly RARAIL-6IL-6RInhibitorInhibitionTocilizumabBiomarkersDMARDsBiologicalDASSDAIAR/BIOMOEG

Outcome Measures

Primary Outcomes (1)

  • Disease Activity Score (DAS-44)

    12 months

Secondary Outcomes (2)

  • Simplified Disease Activity Index (SDAI);Biomarkers Measures

    SDAI at 3-6-12-18 months

  • Biomarkers Measures

    Biomarkers Measures at 3-6-12-18 months

Study Arms (1)

Tocilizumab

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.

Other: Biomarkers Measures

Interventions

Biomarkers MeasuresOTHER

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

Tocilizumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Università Cattolica del Sacro Cuore

Roma, Italy

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidInhibition, Psychological

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Gianfranco Ferraccioli, Prof.

    Dipartimento di Reumatologia, Università Cattolica del Sacro Cuore, Roma

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giovanni Lapadula, Prof.

CONTACT

+39 080 5478866info@oegisea.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2013

First Posted

April 19, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

December 1, 2015

Last Updated

April 19, 2013

Record last verified: 2013-04

Locations

IT(1)