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).
Study Type
OBSERVATIONAL
Enrollment
220
Disease Activity Score (DAS28)
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.
Time frame: Weeks 0, 26, and 52
Matrix Metalloprotease-3 (MMP-3)
MMP-3 level in serum. Positive = \>/= 121.0 ng/mL (male) and 59.7 ng/mL (female)
Time frame: Weeks 0, 26, and 52
Modified Total Sharp Score (mTSS) Change From Week 0 to Week 52
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.
Time frame: Week 0 to Week 52
Health Assessment Questionnaire Disability Index (HAQ-DI)
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Site Reference ID/Investigator# 54680
Anjo, Japan
Site Reference ID/Investigator# 54677
Aomori, Japan
Site Reference ID/Investigator# 54516
Chiba, Japan
Site Reference ID/Investigator# 54660
Chiba, Japan
Site Reference ID/Investigator# 54683
Chiba, Japan
Site Reference ID/Investigator# 54521
Fukuoka, Japan
Site Reference ID/Investigator# 39854
Gifu, Japan
Site Reference ID/Investigator# 54666
Hamamatsu, Japan
Site Reference ID/Investigator# 54682
Hiroshima, Japan
Site Reference ID/Investigator# 54669
Hyōgo, Japan
...and 65 more locations
Time frame: Weeks 0, 26, and 52
Number of Participants With Adverse Events (AEs)
Adverse events (AEs) were collected from week 0 till the end of the study. Please see Adverse Event section below for more details.
Time frame: Week 0 to Week 52