NCT01432366

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

October 1, 2010

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2011

Completed
26 days until next milestone

First Posted

Study publicly available on registry

September 13, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 20, 2016

Completed
Last Updated

January 20, 2016

Status Verified

December 1, 2015

Enrollment Period

3.2 years

First QC Date

August 18, 2011

Results QC Date

December 14, 2015

Last Update Submit

December 14, 2015

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Correlation Between Beliefs About Medicines Questionnaire (BMQ) Necessity Score and Disease Activity Score Based on 28 Joints Count (DAS28) at Month 12

    Correlation between BMQ necessity and DAS28 was assessed by using Pearson correlation coefficient. BMQ necessity: 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicate degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by total number of items and multiplied by 5 to give total score ranging from 5 to 25 (higher scores=stronger beliefs). DAS28: calculated from number of swollen joint count (SJC); tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (millimeter per hour \[mm/hour\]) and participant's assessment of disease activity (DA) on visual analog scale (VAS) (range 0 \[very well\] to 100 millimeter (mm) \[extremely bad\]). DAS28 less than or equal to (\<=) 3.2=low DA; greater than (\>) 3.2 to \<=5.1=moderate DA; \>5.1=high DA; \<2.6=remission.

    Month 12

Secondary Outcomes (14)

  • Correlation Between Beliefs About Medicines Questionnaire Necessity Score and Safety at Month 12

    Month 12

  • Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Disease Activity Score Based on 28 Joints Count at Month 12

    Month 12

  • Correlation Between Beliefs About Medicines Questionnaire Concerns Score and Safety at Month 12

    Month 12

  • Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Disease Activity Score Based on 28 Joints Count

    Month 6, 12

  • Correlation Between Evolution of Beliefs About Medicines Questionnaire Necessity Score and Safety

    Month 6, 12

  • +9 more secondary outcomes

Study Arms (1)

Rheumatoid arthritis patients treated with SC anti-TNF

Other: SC anti-TNF

Interventions

SC anti-TNFOTHER

Subcutaneous (SC) anti-TNF

Rheumatoid arthritis patients treated with SC anti-TNF

Eligibility Criteria

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

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

You may qualify if:

  • 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

You may not qualify if:

  • Participation in other clinical or observational trials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Algemeen Ziekenhuis St Jan

Bruges, 8000, Belgium

Location

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

First Submitted

August 18, 2011

First Posted

September 13, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2013

Study Completion

January 1, 2015

Last Updated

January 20, 2016

Results First Posted

January 20, 2016

Record last verified: 2015-12

Locations

BE(1)