A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Patients With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01640548
• Other study ID #: ML28372
• Status: Completed
• Phase: N/A
• First received: July 6, 2012
• Last updated: November 1, 2016
• Start date: September 2012
• Est. completion date: June 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Current bDMARDs were defined as those with a start date on or after the date of collection, or those with a start date before the date of collection and an end date on or after the date of collection. NICE guidelines recommend the participants with severe active RA who inadequately responded to prior DMARD treatment (trial of 2 DMARDs, one which includes methotrexate) and were intolerant to methotrexate or the treatment with methotrexate considered inappropriate be treated with a biologic DMARD monotherapy.	9 months	No
Primary	Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD	Traditional DMARDS for RA treatment include methotrexate, sulfasalazine, leflunomide, hydroxychloroquine, gold compounds, penicillamine, cyclosporine, azathioprine, chlorambucil, mercaptopurine, and mycophenolate mofetil medications. Previous RA treatment included all the treatments received prior to switching to current RA treatment.	9 months	No
Primary	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	bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs with concomitant traditional DMARD as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.	9 months	No
Primary	Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy	bDMARDS for RA treatment include etanercept, adalimumab, tocilizumab, rituximab, certolizumab pegol, infliximab, golimumab, abatacept and anakinra medications. Only the most frequently used (> 10% of participants) bDMARDs in monotherapy as previous treatment for RA were reported. If a participant was recorded to have been treated with a single bDMARD more than once, the participant was counted only once per type of bDMARD. If participant received 2 different types of bDMARDs as part of their previous treatment, the participant was counted twice, once per each type of bDMARD; therefore, the percentage of participants did not add up to 100%.	9 months	No
Primary	Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment	All corticosteroids and non-steroidal anti-inflammatory drugs taken as previous and current treatments for RA were coded according to the Roche international non-proprietary name dictionary.	9 months	No
Primary	Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy	Both previous and current bDMARDs were presented together for each subgroup, therefore the percentage of participants under each reason did not add up to 100%.	9 months	No
Secondary	Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)	DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). The formula for calculating DAS28 score using ESR value is: 0.56 x square root (v) of TJC + 0.28 x v(SJC) + 0.70 x log natural (ESR) + 0.014 x global assessment of RA score. The formula for calculating DAS28 score using CRP value is: 0.56 x v(TJC) + 0.28 x v(SJC) + 0.36 x log natural (CRP+1) + 0.014 x global assessment of RA score +0.96. The DAS28 score range was 0-9.4 where higher scores represented higher disease activity.	9 months	No
Secondary	Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods	DAS28 was calculated from the tender joint count (TJC) of 28 joints, swollen joint count (SJC) of 28 joints, ESR (in millimeters/hour) or CRP (in milligrams/liter), and the participant's global assessment of disease activity (visual analog scale: 0=no disease activity to 100=maximum disease activity). TJC and SJC assessed as part of the DAS28 outcome measure assessment were reported.	9 months	No
Secondary	Duration of Treatment With the Current bDMARD Usage in Monotherapy		9 months	No
Secondary	Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA		9 months	No
Secondary	Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA		9 months	No