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

NCT01640548 | Completed Results

• 1 other identifier: ML28372
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 26

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (6)

• 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

• 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

• 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

• 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

• 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

• 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

Secondary Outcomes (5)

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

  9 months

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

  9 months

• 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

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients treated with a biologic in monotherapy for rheumatoid arthritis

You may qualify if:

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (26)

Unknown Facility

Abergavenny, NP7 7EG, United Kingdom

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Basildon, SS16 5NL, United Kingdom

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Basingstoke, RG24 9NA, United Kingdom

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Belfast, BT9 7JB, United Kingdom

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Blackburn, BB2 3HH, United Kingdom

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Bournemouth, BH7 7DW, United Kingdom

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Cambridge, CB2 2QQ, United Kingdom

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Cannock, WS11 5XY, United Kingdom

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Dewsbury, WF13 4HS, United Kingdom

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Dudley, DY1 2HQ, United Kingdom

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Durham, DH15TW, United Kingdom

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Eastbourne, BN21 2UD, United Kingdom

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Edinburgh, EH4 2XU, United Kingdom

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Glasgow, G12 0YN, United Kingdom

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Greenock, PA16 0XN, United Kingdom

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Harlow, CM20 1QX, United Kingdom

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Inverness, IV2 3UV, United Kingdom

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Kirkcaldy, KY2 5AH, United Kingdom

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London, SE18 4QH, United Kingdom

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Portsmouth, PO6 3LY, United Kingdom

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Sheffield, S10 2JF, United Kingdom

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Truro, TR1 3LJ, United Kingdom

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Warrington, WA5 1QG, United Kingdom

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Westbury-on-Trym, Bristol, BS10 5NB, United Kingdom

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Wigan, WN6 9EW, United Kingdom

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Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2012
• First Posted: July 13, 2012
• Study Start: September 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 2, 2016
• Results First Posted: October 2, 2015

Record last verified: 2016-11

Locations

GB (26)