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)
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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)]|
- 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.
- 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.
|Study Start Date:||March 2010|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Participants who continued adalimumab treatment after completion of Study NCT00870467 (M06-859)
Participants who discontinued adalimumab treatment after completion of Study NCT00870467(M06-859)
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163292
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|Study Director:||Aki Kuroki||AbbVie GK|