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

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: August 18, 2011
Last updated: March 19, 2015
Last verified: March 2015
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-αlpha 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 ]

Enrollment: 479
Study Start Date: October 2010
Study Completion Date: January 2015
Primary Completion Date: December 2013 (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.


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

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.

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Please refer to this study by its identifier: NCT01432366

Algemeen Ziekenhuis Sint Jan
Brugge, Belgium, 8000
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01432366     History of Changes
Other Study ID Numbers: 0881A1-4746, B1801047
Study First Received: August 18, 2011
Last Updated: March 19, 2015
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on November 25, 2015