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

Rheumatoid Arthritis Clinical Trial

— PACE  

Official title:

Physical ACtivity in patiEnts With Rheumatoid Arthritis Treated With Adalimumab in Routine Clinical Practice (PACE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756235
• Other study ID #: P13-683
• Status: Completed
• Phase: N/A
• First received: December 20, 2012
• Last updated: November 19, 2015
• Start date: December 2012
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Ethics CommitteeEstonia: Research Ethics CommitteeSerbia: Ethics CommitteeHungary: Institutional Ethics CommitteeUkraine: Ethics CommitteeRomania: Ethics CommitteeBosnia: Federal Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 445
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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)

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Bosnia and Herzegovina	Site Reference ID/Investigator# 95211	Banja Luka
Bosnia and Herzegovina	Site Reference ID/Investigator# 95210	Tuzla
Estonia	Site Reference ID/Investigator# 94536	Tallinn
Estonia	Site Reference ID/Investigator# 94537	Tartu
Hungary	Site Reference ID/Investigator# 91273	Budapest
Hungary	Site Reference ID/Investigator# 91275	Budapest
Hungary	Site Reference ID/Investigator# 129326	Debrecen
Hungary	Site Reference ID/Investigator# 91276	Debrecen
Hungary	Site Reference ID/Investigator# 91277	Debrecen
Hungary	Site Reference ID/Investigator# 91278	Eger
Hungary	Site Reference ID/Investigator# 129325	Gyor
Hungary	Site Reference ID/Investigator# 91293	Gyula
Hungary	Site Reference ID/Investigator# 91294	Heviz
Hungary	Site Reference ID/Investigator# 91295	Kecskemet
Hungary	Site Reference ID/Investigator# 91296	Kistarcsa
Hungary	Site Reference ID/Investigator# 91297	Miskolc
Hungary	Site Reference ID/Investigator# 91298	Nyiregyhaza
Hungary	Site Reference ID/Investigator# 91279	Szeged
Hungary	Site Reference ID/Investigator# 91299	Szekesfehervar
Hungary	Site Reference ID/Investigator# 91300	Szombathely
Hungary	Site Reference ID/Investigator# 91280	Veszprem
Romania	Site Reference ID/Investigator# 100205	Bucharest
Romania	Site Reference ID/Investigator# 93754	Bucharest
Romania	Site Reference ID/Investigator# 93755	Bucharest
Romania	Site Reference ID/Investigator# 93756	Bucharest
Romania	Site Reference ID/Investigator# 93757	Bucharest
Romania	Site Reference ID/Investigator# 96522	Bucharest
Romania	Site Reference ID/Investigator# 96536	Bucharest
Romania	Site Reference ID/Investigator# 96538	Bucharest
Romania	Site Reference ID/Investigator# 95320	Constanta
Romania	Site Reference ID/Investigator# 95319	Craiova
Romania	Site Reference ID/Investigator# 96532	Deva
Romania	Site Reference ID/Investigator# 96575	Deva
Romania	Site Reference ID/Investigator# 95315	Iasi
Romania	Site Reference ID/Investigator# 95316	Iasi
Romania	Site Reference ID/Investigator# 95323	Iasi
Romania	Site Reference ID/Investigator# 96529	Iasi
Romania	Site Reference ID/Investigator# 96530	Iasi
Romania	Site Reference ID/Investigator# 96531	Iasi
Romania	Site Reference ID/Investigator# 104618	Ploiesti
Romania	Site Reference ID/Investigator# 104619	Ploiesti
Romania	Site Reference ID/Investigator# 100015	Sf. Gheorghe jud. Covasna
Romania	Site Reference ID/Investigator# 95322	Stefanesti
Romania	Site Reference ID/Investigator# 96527	Timisoara
Russian Federation	Site Reference ID/Investigator# 94635	Khabarovsk
Russian Federation	Site Reference ID/Investigator# 105460	Moscow
Russian Federation	Site Reference ID/Investigator# 105461	Moscow
Russian Federation	Site Reference ID/Investigator# 105462	Moscow
Russian Federation	Site Reference ID/Investigator# 105463	Moscow
Russian Federation	Site Reference ID/Investigator# 105464	Moscow
Russian Federation	Site Reference ID/Investigator# 105465	Moscow
Russian Federation	Site Reference ID/Investigator# 94632	Moscow
Russian Federation	Site Reference ID/Investigator# 94633	Moscow
Russian Federation	Site Reference ID/Investigator# 94637	Moscow
Russian Federation	Site Reference ID/Investigator# 94640	Moscow
Russian Federation	Site Reference ID/Investigator# 94631	St. Petersburg
Russian Federation	Site Reference ID/Investigator# 94639	Tula
Russian Federation	Site Reference ID/Investigator# 94634	Voronezh
Serbia	Site Reference ID/Investigator# 99075	Belgrade
Serbia	Site Reference ID/Investigator# 99078	Novi Sad
Ukraine	Site Reference ID/Investigator# 113495	Kharkov

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Estonia,  Hungary,  Romania,  Russian Federation,  Serbia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in total Short Questionnaire to Assess Health-enhancing Physical Activity (SQUASH) score		Day 0 to 12 months	No
Secondary	Differences in total physical activity SQUASH score		Day 0 to 9 months	No
Secondary	Differences in *individual physical activity categories' SQUASH scores (*commuting activities, leisure time and sport activities, household activities, activities at work and school)		Day 0 to 12 months	No
Secondary	Difference in DAS28 score		Day 0 to 12 months	No
Secondary	Percentage of patients in clinical disease remission (DAS28<2.6) and low disease activity (LDAS, DAS28<3.2)		Day 0 to 12 months	No
Secondary	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		Day 0 to 12 months	No
Secondary	Difference in HAQ-DI score		Day 0 to Month 12	No
Secondary	Correlation between physical activity (total SQUASH score and individual physical activity categories' SQUASH scores) and DAS28 scores		Day 0 to Month 12	No
Secondary	Correlation between physical activity (total SQUASH score and individual physical activity categories' SQUASH scores) and HAQ-DI scores		Day 0 to Month 12	No
Secondary	Influence of certain sociodemographic factors (age, gender, education and occupation) on physical activity (total SQUASH score and individual physical activity categories' SQUASH scores)		Day 0 to Month 12	No

External Links

•   Link