Clinical trial NCT01866150: A Retrospective, Observational Chart Review of Biologics in Monotherapy Versus the Combination Biologic Plus Methotrexate in Patients With Rheumatoid Arthritis
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 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)
timeFrame: Month 6
Secondary outcomes:
measure: 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
timeFrame: Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
measure: 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.
timeFrame: Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
measure: Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment
timeFrame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
measure: Percentage of Participants by Category of DAS28 Score and Timepoint
timeFrame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
measure: Duration of Treatment
timeFrame: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
measure: Average Methotrexate Dose of Participants on Biological Combination Treatment
timeFrame: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
measure: 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.
timeFrame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
measure: 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
timeFrame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
city: Chelmsford
country: United Kingdom
city: Cosham
country: United Kingdom
city: Derby
country: United Kingdom
city: Dudley
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Harlow
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Norwich
country: United Kingdom
city: Portadown
country: United Kingdom
city: Stoke-on-trent
country: United Kingdom
city: Truro
country: United Kingdom
city: Wigan
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: