Clinical trial NCT01640548: A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis
Official title: A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with a biologic in monotherapy for rheumatoid arthritis

Brief summary: This non-interventional, retrospective, cross sectional chart review study will evaluate the management of rheumatoid arthritis patients with a biologic in monotherapy. Data from eligible patients will be collected from the patient's last visit on the prior rheumatoid arthritis treatment and from the most recent visit for the biological monotherapy.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis by a Rheumatologist
* Patient being prescribed with a biologic in monotherapy

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Percentage (%) of Participants Receiving Biologic Disease Modifying Anti-Rheumatic Drugs (bDMARDs) in Monotherapy as Current Treatment for RA According to National Institute for Health and Clinical Excellence (NICE) Guidelines by Type of bDMARD
timeFrame: 9 months
measure: Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD
timeFrame: 9 months
measure: Percentage of Participants With bDMARD and Concomitant Traditional DMARD Regimen as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy by Type of bDMARD
timeFrame: 9 months
measure: Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy
timeFrame: 9 months
measure: Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment
timeFrame: 9 months
measure: Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy
timeFrame: 9 months
Secondary outcomes:
measure: Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)
timeFrame: 9 months
measure: Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods
timeFrame: 9 months
measure: Duration of Treatment With the Current bDMARD Usage in Monotherapy
timeFrame: 9 months
measure: Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA
timeFrame: 9 months
measure: Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA
timeFrame: 9 months
Other outcomes:
Locations:
city: Abergavenny
country: United Kingdom
city: Basildon
country: United Kingdom
city: Basingstoke
country: United Kingdom
city: Belfast
country: United Kingdom
city: Blackburn
country: United Kingdom
city: Bournemouth
country: United Kingdom
city: Cambridge
country: United Kingdom
city: Cannock
country: United Kingdom
city: Dewsbury
country: United Kingdom
city: Dudley
country: United Kingdom
city: Durham
country: United Kingdom
city: Eastbourne
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Greenock
country: United Kingdom
city: Harlow
country: United Kingdom
city: Inverness
country: United Kingdom
city: Kirkcaldy
country: United Kingdom
city: London
country: United Kingdom
city: Portsmouth
country: United Kingdom
city: Sheffield
country: United Kingdom
city: Truro
country: United Kingdom
city: Warrington
country: United Kingdom
city: Westbury-on-Trym, Bristol
country: United Kingdom
city: Wigan
country: United Kingdom
city: Wolverhampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: