The objective of this study is to explore and describe the disease characteristics, treatment and outcomes of participants with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease or ulcerative colitis as the major disease treated with REMICADE, SIMPONI or STELARA in clinical practice in the emerging regions of North Africa, the Middle East, and Western Asia.
Study Type
OBSERVATIONAL
Enrollment
140
Unnamed facility
Algiers, Algeria
Unnamed facility
Alexandria, Egypt
Unnamed facility
Cairo, Egypt
Unnamed facility
Hawalli Area, Kuwait
Unnamed facility
Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response
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).
Time frame: Year 2/early withdrawal
Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response
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.
Time frame: Year 2/early withdrawal
Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response
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.
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Kuwait City, Kuwait
Unnamed facility
Doha, Qatar
Unnamed facility
Mecca, Saudi Arabia
Unnamed facility
Riyadh, Saudi Arabia
Time frame: Year 2/early withdrawal
Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response
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.
Time frame: Year 2/early withdrawal
Percentage of Participants Achieving ASAS 40 Response
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.
Time frame: Year 2/early withdrawal
Percentage of Participants Achieving ASAS 5/6 Response
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.
Time frame: Year 2/early withdrawal
Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI)
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.
Time frame: Year 2/early withdrawal
Number of Participants With Clinical Remission as Assessed by CDAI
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.
Time frame: Year 2/early withdrawal
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease
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.
Time frame: Baseline, Year 2/early withdrawal
Number of Participants With Clinical Response as Assessed by Mayo Score
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.
Time frame: Year 2/early withdrawal
Number of Participants With Clinical Remission as Assessed by Mayo Score
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.
Time frame: Year 2/early withdrawal
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis
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.
Time frame: Year 2/early withdrawal