ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03006198
Date of registration:	28/12/2016
Prospective Registration:	No
Primary sponsor:	Janssen Pharmaceutica N.V., Belgium
Public title:	Tracking Biologics Along the Silk Road HARIR
Scientific title:	Tracking Biologics Along the Silk Road
Date of first enrolment:	February 4, 2016
Target sample size:	140
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03006198
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Algeria	Egypt	Kuwait	Qatar	Saudi Arabia

Contacts

Name:	Janssen Pharmaceutica N.V., Belgium Clinical Trial
Address:
Telephone:
Email:
Affiliation:	Janssen Pharmaceutica N.V., Belgium

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic; Colitis, Ulcerative

Intervention(s)

Primary Outcome(s)

Number of Participants With Clinical Response as Assessed by Crohn's Disease Activity Index (CDAI) [Time Frame: Year 2/early withdrawal]

Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response [Time Frame: Year 2/early withdrawal]

Number of Participants With Clinical Remission as Assessed by CDAI [Time Frame: Year 2/early withdrawal]

Number of Participants With Clinical Response as Assessed by Mayo Score [Time Frame: Year 2/early withdrawal]

Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response [Time Frame: Year 2/early withdrawal]

Percentage of Participants Achieving ASAS 5/6 Response [Time Frame: Year 2/early withdrawal]

Percentage of Participants Achieving ASAS 40 Response [Time Frame: Year 2/early withdrawal]

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Crohn's Disease [Time Frame: Baseline, Year 2/early withdrawal]

Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Score for Ulcerative Colitis [Time Frame: Year 2/early withdrawal]

Number of Participants With Clinical Remission as Assessed by Mayo Score [Time Frame: Year 2/early withdrawal]

Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Response [Time Frame: Year 2/early withdrawal]

Percentage of Participants Achieving Assessment of SpondyloArthritis International Society (ASAS) 20 Response [Time Frame: Year 2/early withdrawal]

Secondary Outcome(s)

Secondary ID(s)

CR106936

C0168ARA4017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.