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. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT01783730
First received: February 1, 2013
Last updated: July 31, 2014
Last verified: July 2014
  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 in Japanese Rheumatoid Arthritis Patients Who Have no Previous Use of DMARDs and Biological Agents

Resource links provided by NLM:


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: February 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (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
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: NCT01783730

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

  Show 161 Study Locations
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Aki Kuroki, MD AbbVie GK
  More Information

Additional Information:
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: July 31, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by AbbVie:
Rheumatoid arthritis

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

ClinicalTrials.gov processed this record on October 21, 2014