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

NCT01866150 | Completed Results

• 1 other identifier: ML28642
• Study Type: observational
• Target: 476
• Locations: 1 country
• Sites: 15

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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.

  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

  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

  Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)

• Duration of Treatment

  Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy)

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 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (15)

Unknown Facility

Cambridge, CB2 0QQ, United Kingdom

Location

Unknown Facility

Chelmsford, CM1 7ET, United Kingdom

Location

Unknown Facility

Cosham, PO6 3LY, United Kingdom

Location

Unknown Facility

Derby, DE22 3NE, United Kingdom

Location

Unknown Facility

Dudley, DY1 2HQ, United Kingdom

Location

Unknown Facility

Edinburgh, EH4 2XU, United Kingdom

Location

Unknown Facility

Harlow, CM20 1QX, United Kingdom

Location

Unknown Facility

London, E11 1NR, United Kingdom

Location

Unknown Facility

London, SE13 6LH, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, NE7 7DN, United Kingdom

Location

Unknown Facility

Norwich, NR4 7UY, United Kingdom

Location

Unknown Facility

Portadown, BT63 5QQ, United Kingdom

Location

Unknown Facility

Stoke-on-Trent, ST6 7AG, United Kingdom

Location

Unknown Facility

Truro, TR1 3LJ, United Kingdom

Location

Unknown Facility

Wigan, WN6 9EW, 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: May 21, 2013
• First Posted: May 31, 2013
• Study Start: April 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: March 1, 2014
• Last Updated: October 5, 2015
• Results First Posted: October 5, 2015

Record last verified: 2015-09

Locations

GB (15)