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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01736189
Recruitment Status : Active, not recruiting
First Posted : November 29, 2012
Last Update Posted : October 24, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation in Patients With Rheumatoid Arthritis (Combo Study : Adalimumab With High Dose MTX)
Study Start Date : September 14, 2012
Estimated Primary Completion Date : December 25, 2017
Estimated Study Completion Date : December 25, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab
U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Humira
those with an exposure


Outcome Measures

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

Secondary Outcome Measures :
  1. Clinical disease activity index [ Time Frame: at week 12 ]
  2. Clinical disease activity index [ Time Frame: at week 24 ]
  3. Clinical disease activity index [ Time Frame: at week 52 ]
  4. Simplified disease activity index [ Time Frame: at week 12 ]
  5. Simplified disease activity index [ Time Frame: at week 24 ]
  6. Simplified disease activity index [ Time Frame: at week 52 ]
  7. X-ray findings for hands and feet [ Time Frame: at week 52 ]
  8. Health Assessment Questionnaire [ Time Frame: at week 12 ]
  9. Health Assessment Questionnaire [ Time Frame: at week 24 ]
  10. Health Assessment Questionnaire [ Time Frame: at week 52 ]
  11. 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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 99 Years   (Child, Adult, Senior)
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)
Contacts and Locations

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 144 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Sarina Kurimoto, MD Abbvie GK
More Information

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: October 24, 2017
Last Verified: October 2017

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