NCT01756235

Brief Summary

The purpose of this study was to evaluate physical activity and its changes in participants with rheumatoid arthritis (RA) who were treated with adalimumab therapy in clinical practice.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

Typical duration for all trials

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

December 1, 2012

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 25, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 6, 2017

Completed
Last Updated

March 6, 2017

Status Verified

January 1, 2017

Enrollment Period

2.8 years

First QC Date

December 20, 2012

Results QC Date

October 26, 2016

Last Update Submit

January 17, 2017

Conditions

Rheumatoid Arthritis

Keywords

Post-marketing observational study (PMOS) ProtocolRheumatoid ArthritisPhysical ActivityAdalimumabHumira®

Outcome Measures

Primary Outcomes (1)

  • Mean Change From Baseline in Total Physical Activity Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) Score

    The quantitative SQUASH score (scores range from 0 to 17010.000) is calculated as the sum of subscores that capture physical activity related to commuting activities (SQUASH-A), scores range from 0 to 4082.400, leisure time activities (SQUASH-B), scores range from 0 to 6123.600, household activities (SQUASH-C), scores range from 0 to 3402.000, and activity at work and school (SQUASH-D), scores range from 0 to 3402.000. The SQUASH score and its subscores has non-negative values. Higher values indicate a higher individual activity level.

    Month 0 (baseline) and Month 12 (Last Observation Carried Forward (LOCF))

Secondary Outcomes (17)

  • Mean Change From Baseline in Total Physical Activity SQUASH Score

    Month 3, Month 6 and Month 9

  • Mean Change From Baseline in SQUASH-A Scores

    Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF

  • Mean Change From Baseline in SQUASH-B Scores

    Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF

  • Mean Change From Baseline in SQUASH-C Scores

    Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF

  • Mean Change From Baseline in SQUASH-D Scores

    Month 3, Month 6, Month 9, Month 12 and Month 12 LOCF

  • +12 more secondary outcomes

Study Arms (1)

Participants with Rheumatoid Arthritis

Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.

Eligibility Criteria

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

Study population consisted of participants with rheumatoid arthritis (RA) who were treated with adalimumab as per locally approved label and prescription guidelines. The decision to be treated with adalimumab had to be independent from study inclusion.

You may qualify if:

  • Had rheumatoid arthritis (RA) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines
  • Had been started on adalimumab therapy no more than one (1) month prior to the study enrolment
  • Had negative result of tuberculosis (TB) screening test or was receiving TB prophylaxis as per local guidelines
  • Had provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

You may not qualify if:

  • Was unable to walk either due to RA or a comorbid condition
  • Was unable to perform basic self-care activities
  • Had contraindications for treatment with adalimumab

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Global Medical Information
Organization
AbbVie
800-633-9110

Study Officials

  • Elena Smirnova, MD

    AbbVie

    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

December 20, 2012

First Posted

December 25, 2012

Study Start

December 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

March 6, 2017

Results First Posted

March 6, 2017

Record last verified: 2017-01