NCT01667458

Brief Summary

This observational study will evaluate the presence and evolution of fatigue on treatment with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to at least two DMARDs (one of them methotrexate) or to anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2011

Geographic Reach
2 countries

18 active sites

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

September 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

August 15, 2012

Last Update Submit

November 1, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16

    16 months

Secondary Outcomes (7)

  • Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue

    16 months

  • Disease Activity Score DAS28

    16 months

  • Pain: Visual Analogue Scale VAS Pain

    16 months

  • Functional disability: Health Assessment Questionnaire HAQ

    16 months

  • Quality of sleep: VAS

    16 months

  • +2 more secondary outcomes

Study Arms (1)

Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with moderate to severe rheumatoid arthritis with an inadequate response to at least two DMARDs or an inadequate response to anti-TNF treatment, eligible for treatment with RoActemra/Actemra

You may qualify if:

  • Adult patients, \>/= 18 years of age
  • Moderate to severe active rheumatoid arthritis, defined as DAS28 \>/= 3.7
  • Inadequate clinical response to current treatment with \>/= 2 non-biologic DMARDs, 1 of them being methotrexate optimally administered for \>/= 3 months, or inadequate clinical response to anti-TNF therapy
  • Eligible for RoActemra/Actemra treatment in daily clinical practice
  • Absence of evolutive tuberculosis (TB)

You may not qualify if:

  • Hypersensitivity to tocilizumab or any of the excipients
  • Active, severe infections
  • Pregnant or lactating women
  • Participation in any other interventional study
  • Patients with major depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Unknown Facility

Aalst, 9300, Belgium

Location

Unknown Facility

Assebroek, 8310, Belgium

Location

Unknown Facility

Ath, 7800, Belgium

Location

Unknown Facility

Brussels, 1000, Belgium

Location

Unknown Facility

Dinant, 5500, Belgium

Location

Unknown Facility

Gilly (Charleroi), 6000, Belgium

Location

Unknown Facility

Kortrijk, 8500, Belgium

Location

Unknown Facility

Lier, 2500, Belgium

Location

Unknown Facility

Mons, 7000, Belgium

Location

Unknown Facility

Namur, 5000, Belgium

Location

Unknown Facility

Roeselare, 8800, Belgium

Location

Unknown Facility

Seraing, 4100, Belgium

Location

Unknown Facility

Sijsele, 8340, Belgium

Location

Unknown Facility

Turnhout, 2300, Belgium

Location

Unknown Facility

Verviers, 4800, Belgium

Location

Unknown Facility

Waremme, 4300, Belgium

Location

Unknown Facility

Westmalle, 2390, Belgium

Location

Unknown Facility

Luxembourg, 2763, Luxembourg

Location

Related Publications (1)

  • Gossec L, Steinberg G, Rouanet S, Combe B. Fatigue in rheumatoid arthritis: quantitative findings on the efficacy of tocilizumab and on factors associated with fatigue. The French multicentre prospective PEPS Study. Clin Exp Rheumatol. 2015 Sep-Oct;33(5):664-70. Epub 2015 Sep 7.

    PMID: 26344671DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2012

First Posted

August 17, 2012

Study Start

September 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

LU(1)BE(17)