Special Investigation (Follow up Survey of the Study of Adalimumab (D2E7)for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859(NCT00870467) (HOPE 3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01163292
First received: July 14, 2010
Last updated: December 11, 2013
Last verified: December 2013

July 14, 2010
December 11, 2013
March 2010
October 2012   (final data collection date for primary outcome measure)
Disease Activity Score (DAS28) [ Time Frame: Weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
The Disease Activity Score (DAS28) is a combined index used to measure disease activity in participants with rheumatoid arthritis. Calculation of the DAS28 score used the tender joint count (28 joints), swollen joint count (28 joints), patient's global assessment of disease activity, and the erythrocyte sedimentation rate (ESR). DAS 28 (ESR) scores range from 0 (no disease activity) to 9 (maximal disease activity); decrease is indicative of improvement in disease activity.
  • Evaluation of adverse event [ 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
  • Improvement rating on the basis of Disease Activity Score28, [ Time Frame: at week 26 ] [ Designated as safety issue: No ]
  • Improvement rating on the basis of Disease Activity Score28, [ Time Frame: at week 52 ] [ 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 ]
  • X-ray findings for hands and feet, Health Assessment Questionnaire [ Time Frame: at week 52 ] [ 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 ]
Complete list of historical versions of study NCT01163292 on ClinicalTrials.gov Archive Site
  • Matrix Metalloprotease-3 (MMP-3) [ Time Frame: Weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    MMP-3 level in serum. Positive = >/= 121.0 ng/mL (male) and 59.7 ng/mL (female)
  • Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52 [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: No ]
    Modified Total Sharp Score (mTSS) is a method of assessing radiographs used in evaluation of inhibition of joint destruction of disease. Digitized X-rays of hands and feet were obtained, then scored in a blinded manner: for erosion (0 [no damage] to 5 [complete collapse or total destruction of joint]) and for joint space narrowing (0 [no damage] to 4 [complete luxation of joint]). Sum of scores was given as total mTSS (0 [normal] to 380 [maximal disease]). Large positive change in mTSS indicates disease progression; small positive/no change indicates slowing/halting of disease progression.
  • Health Assessment Questionnaire Disability Index (HAQ-DI) [ Time Frame: Weeks 0, 26, and 52 ] [ Designated as safety issue: No ]
    Participants assessed their ability to perform the following tasks: 1) dress/groom; 2) arise; 3) eat; 4) walk; 5) reach; 6) grip; 7) maintain hygiene; and 8) maintain daily activity. Participants assessed their ability to do these tasks over the past week by marking their response on a questionnaire. Possible responses/scores included the following: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Negative mean changes from baseline in the disability index of the HAQ-DI indicated improvement.
  • Number of Participants With Adverse Events (AEs) [ Time Frame: Week 0 to Week 52 ] [ Designated as safety issue: Yes ]
    Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.
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Special Investigation (Follow up Survey of the Study of Adalimumab (D2E7)for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859(NCT00870467)
Humira 40 mg/0.8 mL Syringe for Subcutaneous Injection - Special Investigation (Follow-up Survey of the Study of Adalimumab (D2E7) for Prevention of Joint Destruction in Patients With Rheumatoid Arthritis in Japan (M06-859)]

The present survey was conducted to evaluate the effectiveness and safety of treatment with adalimumab during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859) in participants who continued treatment with adalimumab for 52 weeks.

This survey was conducted to assess the risk and benefit of continuing or discontinuing biological therapy with adalimumab (Humira) during the 52-week period following completion of the treatment period in Study NCT00870467 (M06-859).

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study.

Rheumatoid Arthritis
Not Provided
  • Adalimumab
    Participants who continued adalimumab treatment after completion of Study NCT00870467 (M06-859)
  • Non-Adalimumab
    Participants who discontinued adalimumab treatment after completion of Study NCT00870467(M06-859)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
October 2012
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The participants were patients who continued treatment with adalimumab until the end of the treatment period in the NCT00870467(M06-859) study and provided informed consent to participate in the present follow-up survey.

Exclusion Criteria:

  • Participants who used biological agents other than adalimumab after the period of treatment in the NCT00870467(M06-859) study were excluded from the present follow-up study.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01163292
P12-069
No
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Aki Kuroki AbbVie GK
AbbVie
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP