Study Looking at Longitudinal Changes in Fatigue and Health Status in Rheumatoid Arthritis (RA) Patients Treated With Subcutaneous Anti-TNF-α Therapy

NCT01521884 | Completed Results

• 2 other identifiers: 0881A1-4748B1801046
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

People affected by rheumatoid arthritis are often suffering from fatigue and decreased QOL. In this study we are measuring the impact of SC biologics on these parameters.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (5)

• Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Baseline

  AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.

  Baseline

• Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 6

  AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.

  Month 6

• Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 12

  AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.

  Month 12

• Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 18

  AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.

  Month 18

• Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Component Score at Month 24

  AIMS2 is a disease-specific measure of physical, social, and emotional well-being. It is a 78-item questionnaire assessing 12 scales: moving capacities, walking and dexterity, hand and fingers movements, arm movements, self-care, household activities, social activities, support of family and friends, joint pain, work, nervous tension and psychological condition (anxiety and depression). Each item was scored as 0 (or 1, best situation) to 4 (worst situation). Sub-total score of each of the 12 scales normalized to a maximum of 10. Total score were calculated for AIMS2 Affect (\[Level of tension + Mood\]/2), AIMS2 Physical (\[Mobility level + Walking and bending + Hand and finger function + Arm function + Self Care + Household tasks\]/6), and AIMS2 Symptom (Arthritis pain) with total score range from 0 to 10 for all component scores, where higher scores indicated worse situation.

  Month 24

Secondary Outcomes (4)

• Visual Analog Scale (VAS) Fatigue Score

  Baseline, Month 6, 12, 18, 24

• Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (DAS 28-ESR)

  Baseline, Month 6, 12, 18, 24

• Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)

  Baseline, Month 6, 12, 18, 24

• Health Assessment Questionnaire (HAQ) Total Score

  Baseline, Month 6, 12, 18, 24

Other Outcomes (5)

• Spearman Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Visual Analog Scale (VAS) Fatigue Score

  Baseline, Month 6, 12, 18, 24

• Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale - Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation (DAS 28-ESR)

  Baseline, Month 6,1 2, 18, 24

• Pearson Correlation Coefficient Between Arthritis Impact Measurement Scale- Version 2 (AIMS2) Main Components and Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS 28-CRP)

  Baseline, Month 6, 12, 18, 24

Study Arms (1)

RA Patients treated with SC anti-TNF

Other: SC anti-TNF

Interventions

SC anti-TNF OTHER

SC anti-TNF

RA Patients treated with SC anti-TNF

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 seen in a rheumatology practice

You may qualify if:

• Patients who:
• Are active RA patients (as judged by treating MD)
• Are 18 years of age or older at time of consent
• Are scheduled by their rheumatologist to initiate SC anti-TNF-α therapy + MTX

You may not qualify if:

• Use of biologics (or any experimental drug) in the last 3 months before initiation of SC anti-TNF-α therapy.
• Participation in other clinical or observational trials

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

UZ Gasthuisberg

Leuven, 3000, Belgium

Location

Related Links

• To obtain contact information for a study center near you, click here.

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

Limitations and Caveats

Designation of primary and secondary endpoints was based on study team's inputs, as the endpoints were not prioritized in the study protocol.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2011
• First Posted: January 31, 2012
• Study Start: November 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: February 19, 2015
• Results First Posted: February 19, 2015

Record last verified: 2015-02

Locations

BE (1)