Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier:
First received: November 27, 2012
Last updated: February 24, 2015
Last verified: February 2015

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.

Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation in Patients With Rheumatoid Arthritis (Combo Study : Adalimumab With High Dose MTX)

Resource links provided by NLM:

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Disease activity Score 28 [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Disease activity Score 28 [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Disease activity Score 28 [ Time Frame: at week 52 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical disease activity index [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Clinical disease activity index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Clinical disease activity index [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Simplified disease activity index [ Time Frame: at week 12 ] [ Designated as safety issue: Yes ]
  • Simplified disease activity index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Simplified disease activity index [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • X-ray findings for hands and feet [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Number of patients with adverse events [ Time Frame: at week 52 ] [ Designated as safety issue: Yes ]
    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

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
those with an exposure


Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Single-arm, Multi-center, Prospective Cohort


Inclusion Criteria:

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

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

Exclusion Criteria:

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01736189

  Show 226 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Sarina Kurimoto, MD Abbvie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) ) Identifier: NCT01736189     History of Changes
Other Study ID Numbers: P13-684
Study First Received: November 27, 2012
Last Updated: February 24, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on March 03, 2015