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

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ClinicalTrials.gov Identifier: NCT01866150
Recruitment Status : Completed
First Posted : May 31, 2013
Results First Posted : October 5, 2015
Last Update Posted : October 5, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease
Rheumatoid Arthritis

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Study Type : Observational
Actual Enrollment : 476 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : April 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine


Group/Cohort
Cohort



Primary Outcome Measures :
  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) [ Time Frame: Month 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.


Secondary Outcome Measures :
  1. 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 [ Time Frame: Month 3 and the last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) ]
    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.

  2. 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. [ Time Frame: Months 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) ]
    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.

  3. Change From Baseline in DAS28 at Months 3, 6 and at The Last Visit After Initiation of First-Line Biologic Treatment [ Time Frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) ]
    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.

  4. Percentage of Participants by Category of DAS28 Score and Timepoint [ Time Frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) ]
    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.

  5. Duration of Treatment [ Time Frame: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) ]
    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.

  6. Average Methotrexate Dose of Participants on Biological Combination Treatment [ Time Frame: Baseline up to last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) ]
  7. 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. [ Time Frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) ]
    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.

  8. 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 [ Time Frame: Baseline, Month 3, 6 and last visit (maximum 147.1 months for monotherapy and 189.1 months for combination therapy) ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866150


Locations
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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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01866150     History of Changes
Other Study ID Numbers: ML28642
First Posted: May 31, 2013    Key Record Dates
Results First Posted: October 5, 2015
Last Update Posted: October 5, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors