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Special Investigation in Patients With Rheumatoid Arthritis (HOPE3 Study Follow up Survey (P12-069))

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01346501
First received: April 29, 2011
Last updated: April 22, 2013
Last verified: April 2013
History of Changes
  Purpose

The objectives of this observational sudy are as follows. Main objective is to determine the ability to maintain response after discontinuation of adalimumab treatment.

Secondary objective is to determine radiographic progression in patients participating in the study, including the proportion who display minimal progression.


Condition
Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Extended Observational Study (P12-707: HOPE III Study) of Follow-up Survey (P12-069: HOPE II Study) of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)

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 26 ] [ Designated as safety issue: No ]
  • Disease activity Score 28 [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Disease activity Score 28 [ Time Frame: at week 78 ] [ Designated as safety issue: No ]
  • Disease activity Score 28 [ Time Frame: at week 104 ] [ Designated as safety issue: No ]
  • Matrix metalloprotease-3 [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Matrix metalloprotease-3 [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Matrix metalloprotease-3 [ Time Frame: at week 78 ] [ Designated as safety issue: No ]
  • Matrix metalloprotease-3 [ Time Frame: at week 104 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 78 ] [ Designated as safety issue: No ]
  • Health Assessment Questionnaire [ Time Frame: at week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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

  • Number of patients with adverse events [ Time Frame: at week 104 ] [ 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

  • X-ray findings for hands and feet [ Time Frame: at week 52 ] [ Designated as safety issue: No ]
  • X-ray findings for hands and feet [ Time Frame: at week 104 ] [ Designated as safety issue: No ]

Estimated Enrollment: 125
Study Start Date: May 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Humira
Those with an exposure
Control (Non-Humira)
Patients who discontinue adalimumab treatment after completion of the P12-069 study

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The participants will be patients who have continued the 1-year observational period of P12-069 study.

Criteria

Inclusion Criteria:

  • The participants will be patients who have continued the 1-year observational period of P12-069 study.

Exclusion Criteria:

  • Patients who use biological agents other than adalimumab in the P12-069 observational period will be excluded from the HOPE3 study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346501

  Show 75 Study Locations
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: NCT01346501     History of Changes
Other Study ID Numbers: P12-707
Study First Received: April 29, 2011
Last Updated: April 22, 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

ClinicalTrials.gov processed this record on June 18, 2013