Clinical trial NCT03006198: Tracking Biologics Along the Silk Road
Official title: Tracking Biologics Along the Silk Road
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Colitis, Ulcerative
Lead sponsor: Janssen Pharmaceutica N.V., Belgium
Sponsor class: INDUSTRY
First posted: 2016-12-30
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response
timeFrame: Year 2/early withdrawal
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response
timeFrame: Year 2/early withdrawal
measure: Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response
timeFrame: Year 2/early withdrawal
measure: Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response
timeFrame: Year 2/early withdrawal
measure: Percentage of Participants Achieving ASAS 40 Response
timeFrame: Year 2/early withdrawal
measure: Percentage of Participants Achieving ASAS 5/6 Response
timeFrame: Year 2/early withdrawal
measure: Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI)
timeFrame: Year 2/early withdrawal
measure: Number of Participants With Clinical Remission as Assessed by CDAI
timeFrame: Year 2/early withdrawal
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease
timeFrame: Baseline, Year 2/early withdrawal
measure: Number of Participants With Clinical Response as Assessed by Mayo Score
timeFrame: Year 2/early withdrawal
measure: Number of Participants With Clinical Remission as Assessed by Mayo Score
timeFrame: Year 2/early withdrawal
measure: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis
timeFrame: Year 2/early withdrawal
Secondary outcomes:
Other outcomes:
Locations:
city: Alger
country: Algeria
city: Alexandria
country: Egypt
city: Cairo
country: Egypt
city: Hawalli Area
country: Kuwait
city: Kuwait
country: Kuwait
city: Doha
country: Qatar
city: Makkah
country: Saudi Arabia
city: Riyadh
country: Saudi Arabia
Study officials:
affiliation: Janssen Pharmaceutica N.V., Belgium
name: Janssen Pharmaceutica N.V., Belgium Clinical Trial
role: STUDY_DIRECTOR
References: