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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01736189
First received: November 27, 2012
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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
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: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
those with an exposure

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01736189

Contacts
Contact: AbbVie Japan PMOS Desk +81-3-4577-1125 AbbVie_JPN_info_clingov@abbvie.com
Contact: Tadamichi Kubo tadamichi.kubo@abbvie.com

  Show 213 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Aki Kuroki Abbvie GK
  More Information

Additional Information:
No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01736189     History of Changes
Other Study ID Numbers: P13-684
Study First Received: November 27, 2012
Last Updated: April 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Rheumatoid arthritis

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

ClinicalTrials.gov processed this record on July 20, 2014