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Completed

NCT Number: NCT01640548

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Abergavenny, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 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.

  2. Percentage of Participants Treated With Traditional DMARDs as Their Previous Treatment for RA by Type of DMARD

    Time frame: 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.

  3. 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

    Time frame: 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%.

  4. Percentage of Participants With bDMARD Monotherapy as Previous RA Treatment at Anytime Prior to Switch to bDMARD Monotherapy

    Time frame: 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%.

  5. Percentage of Participants With Concomitant Treatment Other Than DMARDs for RA by Type of Treatment

    Time frame: 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.

  6. Percentage of Participants by Reason for Choosing Previous and Current bDMARDs in Monotherapy

    Time frame: 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%.

Secondary outcomes

  1. Assessment of Disease Activity Score of 28 Joint Count (DAS28) by Either Erythrocyte Sedimentation Ratio (ESR) or C-Reactive Protein (CRP)

    Time frame: 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.

  2. Total Number of Tender Joints and Swollen Joints and Non-Evaluable DAS 28 Joints When Assessed Using Both ESR and CRP Methods

    Time frame: 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.

  3. Duration of Treatment With the Current bDMARD Usage in Monotherapy

    Time frame: 9 months

  4. Duration of Treatment With bDMARDs in Monotherapy as Previous Treatment for RA

    Time frame: 9 months

  5. Duration of Treatment of bDMARD Administered With Concomitant Traditional DMARD as Previous Treatment for RA

    Time frame: 9 months

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 13, 2012
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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