- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006198
Tracking Biologics Along the Silk Road (HARIR)
January 9, 2019 updated by: Janssen Pharmaceutica N.V., Belgium
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 Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
140
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alger, Algeria
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Alexandria, Egypt
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Cairo, Egypt
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Hawalli Area, Kuwait
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Kuwait, Kuwait
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Doha, Qatar
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Makkah, Saudi Arabia
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Riyadh, Saudi Arabia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Participants with confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease, or ulcerative colitis as their major disease for which they will be treated with REMICADE, SIMPONI, or STELARA within clinical practice.
Description
Inclusion Criteria:
- Participant must have a confirmed diagnosis of rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease, or ulcerative colitis. A participant can be included for one disease only; participants with multiple diagnoses should be included for their major disease only
- Initiation of treatment with REMICADE, SIMPONI, or STELARA should be planned at the time of enrollment into this observational study (such treatment should be started within 30 days of enrollment)
- Participant must be either treatment-naïve to biologics or have been treated with no more than 2 different biologic agents before enrollment
- Participant must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
Exclusion Criteria:
- Participant who have previously received treatment with REMICADE, SIMPONI, or STELARA must not be enrolled if they start the same therapy a second time
- Participant has received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 30 days before baseline data collection
- Participant is currently enrolled in an investigational study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Cohort 1: Rheumatoid Arthritis
Participants with Rheumatoid arthritis 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 will be observed for disease characteristics, treatment and outcomes.
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Cohort 2: Ankylosing Spondylitis
Participants with Ankylosing spondylitis 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 will be observed for disease characteristics, treatment and outcomes.
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Cohort 3: Psoriatic Arthritis
Participants with Psoriatic arthritis 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 will be observed for disease characteristics, treatment and outcomes.
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Cohort 4: Crohn's Disease
Participants with Crohn's disease 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 will be observed for disease characteristics, treatment and outcomes.
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Cohort 5: Ulcerative Colitis
Participants with 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 will be observed for disease characteristics, treatment and outcomes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response
Time Frame: Year 2/early withdrawal
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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).
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Year 2/early withdrawal
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Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response
Time Frame: Year 2/early withdrawal
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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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Year 2/early withdrawal
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Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Percentage of Participants Achieving ASAS 40 Response
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Percentage of Participants Achieving ASAS 5/6 Response
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI)
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Number of Participants With Clinical Remission as Assessed by CDAI
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease
Time Frame: Baseline, Year 2/early withdrawal
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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.
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Baseline, Year 2/early withdrawal
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Number of Participants With Clinical Response as Assessed by Mayo Score
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Number of Participants With Clinical Remission as Assessed by Mayo Score
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis
Time Frame: Year 2/early withdrawal
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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.
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Year 2/early withdrawal
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2016
Primary Completion (Actual)
December 1, 2018
Study Completion (Actual)
December 1, 2018
Study Registration Dates
First Submitted
December 28, 2016
First Submitted That Met QC Criteria
December 28, 2016
First Posted (Estimate)
December 30, 2016
Study Record Updates
Last Update Posted (Actual)
January 10, 2019
Last Update Submitted That Met QC Criteria
January 9, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Skin Diseases
- Infections
- Immune System Diseases
- Autoimmune Diseases
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Connective Tissue Diseases
- Gastroenteritis
- Colonic Diseases
- Intestinal Diseases
- Skin Diseases, Papulosquamous
- Spinal Diseases
- Bone Diseases
- Inflammatory Bowel Diseases
- Spondylarthropathies
- Spondylarthritis
- Psoriasis
- Bone Diseases, Infectious
- Ankylosis
- Colitis
- Arthritis
- Arthritis, Rheumatoid
- Arthritis, Psoriatic
- Colitis, Ulcerative
- Spondylitis
- Spondylitis, Ankylosing
Other Study ID Numbers
- CR106936
- C0168ARA4017 (Other Identifier: Janssen Pharmaceutica N.V., Belgium)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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