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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT01640548
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-07-06
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-13
• Study Start: 2012-09
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Results First Submitted: 2015-08-12
• Results First Submitted QC: 2015-09-01
• Results First Posted: 2015-10-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD	9 months	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.
Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy	9 months	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%.
Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy	9 months	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%.
Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment	9 months	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.
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	9 months	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.
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	9 months	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%.

Secondary Outcome Measures

Name	Time	Method
Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods	9 months	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.
Duration of Treatment With the Current bDMARD Usage in Monotherapy	9 months
Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA	9 months
Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA	9 months
Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)	9 months	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 (√) of TJC + 0.28 x √(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 √(TJC) + 0.28 x √(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.