Text Size

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

This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01736189
First received: November 27, 2012
Last updated: March 12, 2013
Last verified: March 2013
History of Changes
  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:

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

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: October 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736189

Contacts
Contact: AbbVie Japan PMOS Desk +81-3-4588-4621 abvj-pmos@abbvie.com
Contact: Toshiro Maeda toshiro.maeda@abbvie.com

Locations
Japan
Site Reference ID/Investigator# 90421 Recruiting
Sayama, Japan
Principal Investigator: Site Reference ID/Investigator# 90421            
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Toshiro Maeda Abbvie GK
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

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: March 12, 2013
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 May 16, 2013