Physical Activity in Patients With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01756235
First received: December 20, 2012
Last updated: August 11, 2014
Last verified: August 2014
  Purpose

Physical activity has positive impacts upon pain, disease activity and functional status in patients with rheumatoid arthritis (RA). Additionally, it may decrease the augmented cardiovascular risk in this patient population. Despite these apparent benefits of physical activity in RA, very little is known about physical activity in patients on biologic therapy. It could be hypothesized that improved control of RA signs and symptoms, better physical function and inhibition of structural damage all make the ground for an increased physical activity in patients treated with biologic agents after inadequate response to conventional Disease Modifying Antirheumatic Drugs (DMARDs).

Adalimumab is the biologic agent which demonstrated unsurpassed efficacy in improving physical function, as well as short- and long-term work productivity outcomes in patients with RA. Therefore, adalimumab is a good candidate biologic agent to evaluate the impact on physical activity in RA.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Difference in total Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) score [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in total physical activity SQUASH score [ Time Frame: Day 0 to 9 months ] [ Designated as safety issue: No ]
  • Differences in *individual physical activity categories' SQUASH scores (*commuting activities, leisure time and sport activities, household activities, activities at work and school) [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  • Difference in DAS28 score [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  • Percentage of patients in clinical disease remission (DAS28<2.6) and low disease activity (LDAS, DAS28<3.2) [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  • Differences in total physical activity SQUASH scores and individual physical activity categories' SQUASH scores between patients in remission or LDAS and those who did not attain remission or LDAS [ Time Frame: Day 0 to 12 months ] [ Designated as safety issue: No ]
  • Difference in HAQ-DI score [ Time Frame: Day 0 to Month 12 ] [ Designated as safety issue: No ]
  • Correlation between physical activity (total SQUASH score and individual physical activity categories' SQUASH scores) and DAS28 scores [ Time Frame: Day 0 to Month 12 ] [ Designated as safety issue: No ]
  • Correlation between physical activity (total SQUASH score and individual physical activity categories' SQUASH scores) and HAQ-DI scores [ Time Frame: Day 0 to Month 12 ] [ Designated as safety issue: No ]
  • Influence of certain sociodemographic factors (age, gender, education and occupation) on physical activity (total SQUASH score and individual physical activity categories' SQUASH scores) [ Time Frame: Day 0 to Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 550
Study Start Date: December 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Rheumatoid Arthritis

Detailed Description:

This Post-marketing Observational Study (PMOS) will be conducted in a prospective, single-arm, multicenter, multi-country format.

According to the requirements for non-interventional or observational studies, no additional diagnostic or monitoring procedures will be applied to the patients included in the study other than those which would ordinarily be applied in the course of the particular therapeutic strategy. Only data which are part of routine will be collected.

As this is an observational, non-interventional study, patient's treatments are determined solely by the treating physician, which falls within the scope of the physician's/institution's general liability insurance coverage.

As this study is observational in nature, the follow-up visits are not interventional and strictly scheduled, but rather left to the judgment of each investigator. The investigator should record visit data in the Case Report Form (CRF) from no more than five (5) visits, which are closest to the 3- month intervals within the 12-month study period for each patient.

Failure to observe these usual practice intervals of patient visits will not constitute a breach or violation of the protocol.

No more than five (5) patient's visits are indicated for CRF completion within the 12-month observational period:

  • Visit 0 (V0): Baseline
  • Visit 1 (V1): Follow-up at 3 months
  • Visit 2 (V2): Follow-up at 6 months
  • Visit 3 (V3): Follow-up at 9 months
  • Visit 4 (V4): Follow-up at 12 months (Study End).

A patient may withdraw from this PMOS at any time without prejudice. If the physician, for any reason, decides it is in the best interest of the patient to permanently discontinue adalimumab, treatment should be stopped. The reason for discontinuation should be documented in the CRF.

  Eligibility

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

This study is a post-marketing observational study (PMOS) in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

Study population will consist of adult (aged ≥18 years) patients with rheumatoid arthritis (RA) that can be treated with adalimumab as per locally approved label and prescription guidelines.

Criteria

Inclusion Criteria:

  1. Has rheumatoid arthritis (RA) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines
  2. Is adult (aged ≥ 18 years)
  3. Has been started on adalimumab therapy no more than one (1) month prior to the study enrolment
  4. Has negative result of tuberculosis (TB) screening test or is receiving TB prophylaxis as per local guidelines
  5. Has 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

Exclusion Criteria:

  1. Is unable to walk either due to RA or a comorbid condition
  2. Is unable to perform basic self-care activities
  3. Has contraindications for treatment with adalimumab (please see the latest version of the locally approved label)
  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: NCT01756235

Contacts
Contact: Kresimir Furkovic, MD +385 1 2350 531 kresimir.furkovic@abbvie.com
Contact: Jonathan Moller, MD +33 1 4560 1185 jonathan.moller@abbvie.com

  Show 95 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Maja Hojnik, MD AbbVie
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01756235     History of Changes
Other Study ID Numbers: P13-683
Study First Received: December 20, 2012
Last Updated: August 11, 2014
Health Authority: Serbia: Ethics Committee
Romania: Ethics Committee
Estonia: Research Ethics Committee
Bosnia: Federal Ministry of Health
Ukraine: Ethics Committee
Russia: Ethics Committee
Hungary: Institutional Ethics Committee

Keywords provided by AbbVie:
Post-marketing observational study (PMOS) Protocol
Physical Activity
Rheumatoid Arthritis

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 October 01, 2014