Correlation Between Beliefs About Medicine and Objective Measures of Efficacy and Safety in Rheumatoid Arthritis (RA) (CONTENT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01432366
First received: August 18, 2011
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

It can be assumed that there is a link between what the patient feels and thinks about his medication and objective measures of disease activity and safety.


Condition Intervention Phase
Rheumatoid Arthritis
Other: SC anti-TNF
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Subcutaneous Anti-tnf-α in Rheumatoid Arthritis: Analyze the Correlation Between Objective Measures of Disease Activity and Safety and a Subjective Measure Such As Patient Beliefs About a Medicine

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Correlation between patient beliefs about subcutaneous anti-TNF's Necessity and Disease Activity Score (DAS28) at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Correlation between Belief about Medicines Questionnaire (BMQ) Necessity and Safety at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Correlation between BMQ Concerns and DAS 28 at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Correlation between BMQ Concerns and Safety at year 1. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: October 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rheumatoid arthritis patients treated with SC anti-TNF Other: SC anti-TNF
Subcutaneous (SC) anti-TNF

Detailed Description:

A total of 500 subjects will provide 80% power to test the hypothesis that the absolute value of the correlation between two measures (e.g., BMQ Necessity and DAS28) is ≤ 0.3 (i.e., H0:│r│ ≤ 0.3 ) versus the alternative that it is > 0.3 (i.e., H1:│r │ > 0.3 ) assuming the absolute value of the true correlation is 0.40. A total of 500 will be enrolled to allow for approximately 5% being lost from analysis due to lack of post baseline data.

The Pearson method will be used for correlation between the BMQ total score for Necessity and the DAS28 and between the BMQ total score for Concern and DAS28. The Spearman rank method will be used for correlation between the BMQ total scores and Safety. For these latter analyses, subjects will be classified into one of 3 safety categories: (1) No AEs, (2) Non-serious AEs, (3) Serious AEs. 95% confidence intervals for the correlations will be provided.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

rheumatoid arthritis patients treated with SC anti-TNF capable of completing some questionnaires

Criteria

Inclusion Criteria:

Patients with RA on stable therapy defined as:

Etanercept: 1x50 mg/week or 2x25mg/week for at least 1 consecutive year. Adalimumab: 1x40 mg every other week for at least 1 consecutive year. Oral corticosteroids: stable doses for ≥ 12 weeks before baseline Methotrexate: stable doses for ≥ 12 weeks before baseline Other DMARD's: stable doses for ≥ 12 weeks before baseline

Exclusion Criteria:

Participation in other clinical or observational trials.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01432366

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

Locations
Belgium
Algemeen Ziekenhuis Sint Jan Recruiting
Brugge, Belgium, 8000
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01432366     History of Changes
Other Study ID Numbers: 0881A1-4746, B1801047
Study First Received: August 18, 2011
Last Updated: July 14, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014