A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis

A Retrospective Chart Review on the Use of Biologics in Monotherapy for the Treatment of Rheumatoid Arthritis: A Comparison of the Effectiveness of Biologic Monotreatment and Biologic and Methotrexate (MTX) Combination Treatment

This cross-sectional, non-interventional, retrospective chart review will compare the efficacy and safety of biologic monotherapy and biologic and methotrexate combination therapy in patients with rheumatoid arthritis who have had an inadequate response to prior treatment with disease-modifying anti-rheumatic drugs including methotrexate. Data will be collected from patients who have been on first-line biologic treatment for at least 6 months.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis

• Study Type: Observational
• Enrollment (Actual): 476

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridge, United Kingdom, CB2 0QQ
  • Chelmsford, United Kingdom, CM1 7ET
  • Cosham, United Kingdom, PO6 3LY
  • Derby, United Kingdom, DE22 3NE
  • Dudley, United Kingdom, DY1 2HQ
  • Edinburgh, United Kingdom, EH4 2XU
  • Harlow, United Kingdom, CM20 1QX
  • London, United Kingdom, E11 1NR
  • London, United Kingdom, SE13 6LH
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
  • Norwich, United Kingdom, NR4 7UY
  • Portadown, United Kingdom, BT63 5QQ
  • Stoke-on-trent, United Kingdom, ST6 7AG
  • Truro, United Kingdom, TR1 3LJ
  • Wigan, United Kingdom, WN6 9EW

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with rheumatoid arthritis with an inadequate response to at least 2 DMARD treatments, one of which includes methotrexate, who are being treated with first-line biologic therapy

Description

Inclusion Criteria:

• Adult patients, >/= 18 years of age
• Diagnosis of rheumatoid arthritis by a rheumatologist
• Patients who have responded inadequately to methotrexate or disease-modifying anti-rheumatic drugs (DMARDs) and are being prescribed a biologic in monotherapy or in combination with methotrexate and other classical DMARDs as per NICE guidelines

Exclusion Criteria:

• Primary diagnosis of a condition other than rheumatoid arthritis
• Current treatment with a biologic in combination without methotrexate
• Prior treatment with an experimental agent for rheumatoid arthritis

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved Disease Activity Score Based on 28-joint Count (DAS-28) and Erythrocyte Sedimentation Rate (DAS28-ESR) Remission at 6 Months (DAS28<2.6)	The DAS28 score is a measure of the participant's disease activity calculated using the tender joint count (TJC) [28 joints], swollen joint count (SJC) [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. DAS28 equals (=) (0.56 multiplied by [*] the square root [√] of TJC) plus (+) (0.28 * √ of SJC) + (0.70 * the natural logarithm [ln] ESR in millimeters per hour [mm/h]) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score <2.6.	Month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved DAS28-ESR Remission (DAS28-ESR <2.6) at 3 Months and at the Last Visit After Initiation of First-Line Biologic Treatment	The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. DAS28 = (0.56 * √ of TJC) + (0.28 * √ of SJC) + (0.70 * ln ESR in mm/h) + (0.014 * participant's global assessment of disease activity). DAS28 Remission is defined as a DAS28 score < 2.6.	Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Percentage of Participants Who Achieved Low Disease Activity (LDA) (DAS28-ESR <3.2) at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.	The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and the ESR for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6. LDA was defined as a DAS28 score <3.2.	Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment	The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or C Reactive Protein (CRP) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.	Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Percentage of Participants by Category of DAS28 Score and Timepoint	The DAS28 score is a measure of the participant's disease activity calculated using the TJC [28 joints], SJC [28 joints], participant's global assessment of disease activity [visual analog scale: 0=no disease activity to 100=maximum disease activity] and either ESR or CRP for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score <2.6.	Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Duration of Treatment	Drug retention was defined as the total duration of time in months the participant was on treatment (combination therapy or monotherapy). The duration was the time in months between the start date of biologic therapy to the date of most recent visit.	Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Average Methotrexate Dose of Participants on Biological Combination Treatment		Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in Total Number of Tender Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment.	The 28 joints to be assessed for tenderness were shoulder, elbow, wrist, metacarpophalangeal (MCP) joints 1-5, proximal interphalangeal (PIP) joints 1-5, and knee on both sides of the body. The sum of tender joints ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.	Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Change From Baseline in Total Number of Swollen Joints at Months 3 and 6 and at the Last Visit After Initiation of First-Line Biologic Treatment	The 28 joints to be assessed for swelling were shoulder, elbow, wrist, MCP joints 1-5, PIP joints 1-5, and knee on both sides of the body. The sum of swollen joints, each, ranged from 0 to 28 with 0 as best possible health status and 28 as worst health status.	Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: May 21, 2013
• First Submitted That Met QC Criteria: May 27, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Estimate): October 5, 2015
• Last Update Submitted That Met QC Criteria: September 1, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: ML28642