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Special Investigation in Patients With Rheumatoid Arthritis (Combo Study; Adalimumab With High Dose Methotrexate)

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ClinicalTrials.gov Identifier: NCT01736189
Recruitment Status : Completed
First Posted : November 29, 2012
Last Update Posted : May 10, 2018
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
In the usual clinical setting, patients with Rheumatoid Arthritis who receive adalimumab (Humira®) and high-dose Methotrexate (≥12 mg/week) will be investigated prospectively for effectiveness according to Disease Activity Score 28, modified Total Sharp Score, and other measures, as well as safety in terms of the incidence and pattern of occurrence of adverse drug reactions.

Condition or disease
Rheumatoid Arthritis

Study Type : Observational
Actual Enrollment : 345 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation in Patients With Rheumatoid Arthritis (Combo Study : Adalimumab With High Dose MTX)
Actual Study Start Date : September 14, 2012
Actual Primary Completion Date : April 16, 2018
Actual Study Completion Date : April 16, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Group/Cohort
Humira
those with an exposure



Primary Outcome Measures :
  1. Disease activity Score 28 [ Time Frame: at week 12 ]
  2. Disease activity Score 28 [ Time Frame: at week 52 ]
  3. Disease activity Score 28 [ Time Frame: at week 24 ]

Secondary Outcome Measures :
  1. Simplified disease activity index [ Time Frame: at week 52 ]
  2. Health Assessment Questionnaire [ Time Frame: at week 12 ]
  3. Health Assessment Questionnaire [ Time Frame: at week 52 ]
  4. Simplified disease activity index [ Time Frame: at week 12 ]
  5. Health Assessment Questionnaire [ Time Frame: at week 24 ]
  6. Simplified disease activity index [ Time Frame: at week 24 ]
  7. Clinical disease activity index [ Time Frame: at week 12 ]
  8. Number of patients with adverse events [ Time Frame: at week 52 ]
    Occurrence of adverse event (yes or no), nature of adverse events, date of onset, seriousness,clinical course of adverse events, outcome, measures, causal relationship between the event and Humira

  9. Clinical disease activity index [ Time Frame: at week 24 ]
  10. X-ray findings for hands and feet [ Time Frame: at week 52 ]
  11. Clinical disease activity index [ Time Frame: at week 52 ]


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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Single-arm, Multi-center, Prospective Cohort
Criteria

Inclusion Criteria:

The subjects of this study are RA patients and to whom adalimumab is administered. They should be satisfying the following conditions:

  • Disease duration of RA ≤2 years
  • MTX administration ≥3 months
  • Dose of MTX ≥12mg/week
  • DAS28-CRP >3.2

Exclusion Criteria:

  • Patients who have been previously treated with biologics (including TNF inhibitors others)

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): NCT01736189


  Show 137 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: AbbVie Inc. AbbVie

Additional Information:
Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01736189     History of Changes
Other Study ID Numbers: P13-684
First Posted: November 29, 2012    Key Record Dates
Last Update Posted: May 10, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents