An Observational Study of the Impact of RoActemra/Actemra on Fatigue in Patients With Rheumatoid Arthritis (PEPS)

NCT01185522 | Completed Results

• 1 other identifier: ML22457
• Study Type: observational
• Target: 719
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, observational study will assess the effect of RoActemra/Actemra (tocilizumab) on fatigue in patients with moderate to severe rheumatoid arthritis who have an inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti tumor necrosis factor (anti-TNF) drugs. Eligible patients receiving RoActemra/Actemra according to the standard of care will be followed for 4 months.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Percentage of Participants With a Clinically Significant Improvement in Fatigue After 4 Months of Tocilizumab Treatment

  Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue score assesses self-reported fatigue and its impact upon daily activities and function. It is calculated with 13-item questionnaire on 5-point scale: 0 (not at all) to 4 (very much). The larger the participant's response to the questions (exception of 2 negatively stated), the greater the participants fatigue. For all questions (except for 2 negatively stated), the code is reversed and a new score is calculated as 4 minus the participant's response. The sum of all responses resulted a total possible score of 0 (worse score) to 52 (better score). A higher score reflects an improvement in the participant's health status. Clinically relevant improvement is defined as a \>= 4-point change from Baseline. This was performed using the last observation carried forward (LOCF) method and for participants who completed a FACIT-Fatigue score at Month 4 (completers).

  At Month 4

• Number of Participants With Clinically Significant Improvement in Fatigue at Month 4 With Respect to Predictive Factors

  Predictive factors of fatigue were taken into account included gender, age, time since initial diagnosis, Erosive RA, disease activity score (DAS, ranging from 0 \[no disease activity\] to 10 \[worsening in disease activity\]), erythrocyte sedimentation rate (ESR), anemia, treatment with corticosteroids, doses of corticosteroids, health assessment questionnaire (HAQ, ranging from 0 \[without any difficulty\] to 60 \[worsening or unable to do physical activities\]), FACIT-Fatigue score (ranging from 0 \[worse score\] to 52 \[better score\]), visual analogue score (VAS) for fatigue, pain, quality of sleep, and global assessment (ranging from 0 \[symptom-free and no arthritis symptoms\] to 100 \[worsening of symptoms and arthritis disease activity\]), Short Form 36 (SF36) vitality score (ranging from 0 \[worst\] to 100 \[best\]), Hospital Anxiety and Depression Scale (HADS; represented as score \</= 7 \[no case\], 7 to 10 \[doubtful case\], and \> 10 \[certain case of HAD\]).

  At Month 4

• Median Clinically Significant Improvement in C-Reactive Protein as a Predictive Factors After 4 Months of Tocilizumab Treatment

  Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen. C-reactive protein (CRP) is one of the biomarkers for the diagnosis and assessment of disease activity in RA.

  At Month 4

• Mean Clinically Significant Improvement in Tender Joints and Swollen Joints as Predictive Factors After 4 Months of Tocilizumab Treatment

  Predictive factors were characteristics of participants that indicated greater or lesser likelihood of responding to a specific treatment regimen. For tender joint count (TJC), a total of 68 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no tender joint) to 68 (worse possible score or all tender joints). Lower scores indicate no tender joint and higher scores indicate worsening tender joints. For swollen joint count (SJC), a total of 66 joints were assessed. The presence of a tender joint was scored as 1 and absence as 0. Total score is calculated by adding the scores, which is ranging from 0 (best possible score or no swollen joint) to 66 (worse possible score or all swollen joints). Lower scores indicate no swollen joint and higher scores indicate worsening swollen joints.

  At Month 4

Secondary Outcomes (17)

• Baseline Disease Characteristics: Mean Disease Duration

  Baseline (Day [D] 0)

• Baseline Disease Characteristics: Number of Participants With Positive Rheumatoid Factor and/or Anti-cyclic Citrullinated Protein Antibodies

  Baseline (D0)

• Baseline Disease Characteristics: Tender Joint Count and Swollen Joint Count

  Baseline (D0)

• Baseline Disease Characteristic: DAS28, Patient's Global Assessment, VAS Pain and HAQ Score as Rheumatoid Arthritis Assessment Parameters

  Baseline (D0)

• Baseline Disease Characteristic: Number of Participants With High Erythrocyte Sedimentation Rate, CRP Level, Anemia, and Unacceptable Patient Acceptable Symptom State Fatigue

  Baseline (D0)

Study Arms (1)

Tocilizumab

Eligible participants receiving tocilizumab according to summary of product characteristics in a real life setting will be observed for 4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with inadequate response to DMARDs or anti-TNF receiving RoActemra/Actemra according to standard of care

You may qualify if:

• Adult patients, \>/= 18 years of age
• Moderate to severe rheumatoid arthritis
• Inadequate response to disease-modifying antirheumatic drugs (DMARDS) or anti-TNF (tumor necrosis factor) drugs

You may not qualify if:

• Hypersensitivity to RoActemra/Actemra or any component
• Active infection
• Participation in a clinical trial in rheumatoid arthritis

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Unknown Facility

Neuilly-sur-Seine, 92521, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Roche Trial Information Hotline
• Organization: F. Hoffmann-La Roche AG

global.trial_information@roche.com

+41 616878333

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: August 18, 2010
• First Posted: August 20, 2010
• Study Start: January 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: June 23, 2016
• Results First Posted: June 23, 2016

Record last verified: 2016-05

Locations

FR (1)