NCT01462162

Brief Summary

This prospective observational study will investigate the effect of tocilizumab on fatigue in participants with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs or anti-tumour necrosis factor (anti-TNF) drugs. Data will be collected from participants for 6 months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2011

Typical duration for all trials

Geographic Reach
1 country

16 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
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 31, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
3 years until next milestone

Results Posted

Study results publicly available

October 31, 2016

Completed
Last Updated

October 31, 2016

Status Verified

September 1, 2016

Enrollment Period

2.2 years

First QC Date

October 27, 2011

Results QC Date

December 1, 2015

Last Update Submit

September 8, 2016

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

  • Regression Coefficient Between Change in Fatigue Score as Measured by the Functional Assessment of Chronic Illness Therapy-Fatigue Scale (FACIT-F) at Week 12 and Change in Main Variables at Week 12

    Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.

    Week 12

  • Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 24 and Change in Main Variables at Week 24

    Regression analysis between change in FACIT-F scale and change in following variable were assessed: DAS28-ESR (total score range: 0-9.4, higher score=more disease activity), Epworth sleepiness scale (total score range: 0-24, higher score=higher degree of sleepiness), back depression inventory (total score range: 0-63, score higher than 18 indicates moderate to severe symptoms of depression). The total score of the FACIT-F questionnaire ranges from 0=worse score to 52=better score. Regression coefficient (R) and coefficient of determination (R\^2) were calculated. Difference (1-R\^2)=the variation in the changes in fatigue not explained by independent variables, that is, independent contribution of these changes in fatigue to the assessment of RA. Only variables with available data were reported.

    Week 24

Secondary Outcomes (20)

  • Change From Baseline to Week 12 and 24 in Fatigue Score as Assessed by FACIT-F

    Baseline, Week 12, Week 24

  • Change From Baseline to Week 12 and 24 in Serum Hemoglobin

    Baseline, Week 12, 24

  • Regression Coefficient Between Change in Fatigue Score as Measured by the FACIT-F at Week 12 and 24 With Change in Disease Activity Parameters at Week 12 and 24

    Week 12, 24

  • Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24

    Week 12, 24

  • Regression Coefficient Between Change in Hemoglobin Level at Week 12, 24 and Change in Disease Activity at Week 12 and 24 - Safety Population

    Week 12, 24

  • +15 more secondary outcomes

Study Arms (1)

Rheumatoid Arthritis Participants

Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center will be followed-up for 6 months.

Drug: Tocilizumab

Interventions

TocilizumabDRUG
Also known as: RoActemra, Actemra
Rheumatoid Arthritis Participants

Eligibility Criteria

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

Patients with Rheumatoid Arthritis

You may qualify if:

  • Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab according to his/her clinical judgment and the conditions approved in the Summary of Product Characteristics (SPC).

You may not qualify if:

  • Participants previously or currently treated with RoActemra/Actemra in clinical trials
  • Absolute neutrophil count less than or equal to (\</=) 2x10\^9 per liter (/L)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Unknown Facility

Barcelona, Barcelona, 08035, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08907, Spain

Location

Unknown Facility

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

Location

Unknown Facility

Mollet del Vallès, Barcelona, 08100, Spain

Location

Unknown Facility

Sabadell, Barcelona, 08208, Spain

Location

Unknown Facility

Sant Joan Despí, Barcelona, 08970, Spain

Location

Unknown Facility

Girona, Girona, 17002, Spain

Location

Unknown Facility

A Coruña, La Coruña, 15405, Spain

Location

Unknown Facility

Lugo, Lugo, 27880, Spain

Location

Unknown Facility

Cartagena, Murcia, 30203, Spain

Location

Unknown Facility

El Palmar, Murcia, 30120, Spain

Location

Unknown Facility

Lorca, Murcia, 30800, Spain

Location

Unknown Facility

Ourense, Orense, 32005, Spain

Location

Unknown Facility

Vigo, Pontevedra, 36204, Spain

Location

Unknown Facility

Tarragona, Tarragona, 43003, Spain

Location

Unknown Facility

Tarragona, Tarragona, 43204, Spain

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Medical Communications
Organization
Hoffmann-LaRoche
genentech@druginfo.com
800-821-8590

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

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

Study Record Dates

First Submitted

October 27, 2011

First Posted

October 31, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

October 31, 2016

Results First Posted

October 31, 2016

Record last verified: 2016-09

Locations

ES(16)