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Special Investigation in Rheumatoid Arthritis Patient Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

This study is currently recruiting participants.
Verified April 2013 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01783730
First received: February 1, 2013
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

This study will be conducted to examine the safety profile and the effectiveness in daily clinical practice of adalimumab in rheumatoid arthritis patients showing rapid progression of structural damage of the joints, who have no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Investigation Assessment of the Safety of Adalimumab in Rheumatoid Arthritis Patients Showing Rapid Progression of Structural Damage of the Joints, Who Have no Prior History of Treatment With Disease-modifying Anti-rheumatic Drugs or Biological Agents

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Disease Activity Score 28 [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • 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 ]
  • Number of patients with adverse events [ Time Frame: at week 24 ] [ 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


Secondary Outcome Measures:
  • Clinical disease activity index [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • 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 ]
  • Simplified disease activity index [ Time Frame: at week 4 ] [ Designated as safety issue: No ]
  • Simplified disease activity index [ Time Frame: at week 12 ] [ Designated as safety issue: No ]
  • Simplified disease activity index [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (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

Rheumatoid Arthritis patients showing rapid progression of structural damage of the joints, who have no prior history of treatment with disease-modifying anti-rheumatic drugs or biological agents.

Criteria

Inclusion Criteria:

Rheumatoid Arthritis patients meeting all of the following requirements will be the subjects of this study.

  1. High disease activity, with poor prognostic factors
  2. Combination of adalimumab and Methotrexate will be started
  3. No prior history of treatment with disease-modifying anti-rheumatic drugs
  4. No prior history of treatment with biological agents
  5. Adalimumab is dosed according to the registered product label
  6. Signed informed consent

Exclusion Criteria:

There are no specific exclusion criteria.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01783730

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

Locations
Japan
Site Reference ID/Investigator# 98875 Recruiting
Izumisano, Japan
Principal Investigator: Site Reference ID/Investigator# 98875            
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Toshiro Maeda, MD AbbVie GK
  More Information

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

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT01783730     History of Changes
Other Study ID Numbers: P13-983
Study First Received: February 1, 2013
Last Updated: April 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
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013