Tracking Biologics Along the Silk Road

Number of Participants With Clinical Response as Assessed by Mayo Score

时间窗: Year 2/early withdrawal

Clinical response is defined as a decrease from baseline in the Mayo score by greater than or equal to 30 percent and \>= 3 points, and a decrease from baseline in the rectal bleeding sub score to 0 or 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicate worsening of the disease.

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis

时间窗: Year 2/early withdrawal

The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.

Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response

时间窗: Year 2/early withdrawal

The ACR 70 Response is defined as \>=70 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=70 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, \[0 mm=no pain to 100 mm=worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and CRP.

Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response

时间窗: Year 2/early withdrawal

The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20 percent improvement from baseline and an absolute change \>= 10 units on a 0-10 scale (0=no disease activity; 10=high disease activity) for \>= 3 domains, and no worsening in remaining domain.

Percentage of Participants Achieving ASAS 40 Response

时间窗: Year 2/early withdrawal

The ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) participants in 4 domains: participant global assessment of disease activity, pain, function, inflammation. The ASAS 40 = 40 percent improvement from baseline and an absolute change \>= 20 units on a 0-10 scale (0=no disease activity, 10=high disease activity) for \>= 3 domains, and no worsening in remaining domain.

Percentage of Participants Achieving ASAS 5/6 Response

时间窗: Year 2/early withdrawal

ASAS 5/6 response is a validated composite assessment, reflecting the proportion of treated patients who achieve within a defined timeframe at least 20 percent improvement in score in at least 5 of a conventional set of 6 clinical domains relevant to AS and no worsening in the remaining domain.

Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response

时间窗: Year 2/early withdrawal

The ACR 20 Response is defined as greater than or equal to (\>=) 20 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=20 percent improvement in 3 of following 5 assessments: patient's assessment of pain using Visual Analog Scale (VAS; 0-10 millimeter \[mm\], 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, \[0 mm=no pain to 100 mm=worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by Health Assessment Questionnaire-Disability Index (HAQ-DI, defined as a 20-question instrument assessing 8 functional areas. The derived HAQ-DI ranges from 0, indicating no difficulty, to 3, indicating inability to perform a task in that area) and serum C-Reactive Protein (CRP).

Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI)

时间窗: Year 2/early withdrawal

The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. Clinical response defined as reduction of greater than or equal to 70 points and/or 25 percent from baseline in CDAI.

Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response

时间窗: Year 2/early withdrawal

The ACR 50 Response is defined as \>=50 percent improvement in swollen joint count (66 joints) and tender joint count (68 joints) and \>=50 percent improvement in 3 of following 5 assessments: patient's assessment of pain using VAS (0-10 mm, 0 mm=no pain and 10 mm=worst possible pain), patient's global assessment of disease activity by using VAS (the scale ranges from 0 mm to 100 mm, \[0 mm=no pain to 100 mm=worst possible pain\]), physician's global assessment of disease activity using VAS, participant's assessment of physical function measured by HAQ-DI and serum CRP.

Number of Participants With Clinical Remission as Assessed by Mayo Score

时间窗: Year 2/early withdrawal

Clinical remission is defined as a Mayo score less than or equal to 2 points, with no individual sub score greater than 1. The Mayo score consists of 4 sub scores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 sub scores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe. Higher scores indicate worsening of the disease.

Number of Participants With Clinical Remission as Assessed by CDAI

时间窗: Year 2/early withdrawal

The CDAI will be assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s) and/or opiates, and general well-being. The last 4 variables are scored over 7 days by the participant on a diary card. Remission will be defined as CDAI less than (\<) 150 points.

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease

时间窗: Baseline, Year 2/early withdrawal

The IBDQ is a 32-item questionnaire used to assess quality of life in participants with inflammatory bowel diseases. Each question has graded responses from 1 (worst situation) to 7 (best situation). Total score ranges from 32 (worst) to 224 (best). Higher scores indicate better quality of life.