NCT01245452

Brief Summary

To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to Methotrexate alone. The secondary endpoints : analyze the clinical efficacy of Tocilizumab in this population and correlate the CRE response with other marker (CRP, Hb, DAS, HAQ) and evaluate the safety profile of Tocilizumab.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started May 2010

Typical duration for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

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

May 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

3.1 years

First QC Date

November 19, 2010

Last Update Submit

October 30, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisTocilizumabCardiorespiratory endurance

Outcome Measures

Primary Outcomes (1)

  • To measure the CRE by a work capacity index obtained in a submaximal testing (W65%/kg) in early RA patients treated with tocilizumab compared to Methotrexate alone.

    not necessary

    2 years

Secondary Outcomes (4)

  • To analyze the clinical efficacy of Tocilizumab in this population.

    2 years

  • To correlate the CRE response with other marker (CRP, Hb, Disease activity score DAS, HAQ).

    2 years

  • To evaluate the safety profile of Tocilizumab.

    2 years

  • To assess the effect of Tocilizumab on synovial histopathology of early RA

    2 years

Study Arms (2)

Tocilizumab

EXPERIMENTAL

Tocilizumab (8 mg/kg monthly from week 0 to 20)

Drug: Tocilizumab

Methotrexate

ACTIVE COMPARATOR

MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8

Drug: Methotrexate

Interventions

TocilizumabDRUG

Tocilizumab (8 mg/kg monthly from week 0 to 20)

Also known as: Roche EU/1/08/492/001, ATC code L04AC07
Tocilizumab
MethotrexateDRUG

MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8

Methotrexate

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of RA (according to American College of Rheumatology ACR criteria)
  • Disease duration \< 2 years.
  • Age between 18 and 70 years old.
  • Active RA defined by a disease activity score 28 DAS28-CRP score \> 3.2 with a swollen joint count ≥ 4
  • MTX naive
  • Stable therapy with corticosteroids or nonsteroidal anti-inflammatory drug NSAIDs
  • Presence of knee arthralgia or synovitis (addendum protocol with synovial biopsy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Université Catholique de Louvain

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumabMethotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Patrick DUREZ, Md

    Université Catholique de Louvain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professeur clinique

Study Record Dates

First Submitted

November 19, 2010

First Posted

November 22, 2010

Study Start

May 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

October 31, 2013

Record last verified: 2013-10

Locations

BE(1)