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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:	16 October 2023
Main ID:	NCT03976245
Date of registration:	03/06/2019
Prospective Registration:	Yes
Primary sponsor:	Lawson Health Research Institute
Public title:	Advanced Therapeutics in Rheumatoid Arthritis (RA)
Scientific title:	Advanced Therapeutics in Rheumatoid Arthritis (RA)
Date of first enrolment:	March 1, 2020
Target sample size:	144
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/ct2/show/NCT03976245
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	Phase 4

Countries of recruitment
Canada

Contacts

Name:	Janet E Pope
Address:
Telephone:	519-646-6332
Email:	janet.pope@sjhc.london.on.ca
Affiliation:

Name:	Janet E Pope, MD MPH
Address:
Telephone:	519 646-6000
Email:	janet.pope@sjhc.london.on.ca
Affiliation:

Name:	Janet E Pope, MD MPH
Address:
Telephone:
Email:
Affiliation:	Western University, Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with RA who meet criteria for obtaining an advanced therapeutic through usual
care

- active RA with 5 or more swollen joints

- seropositive

- presence of erosions

- failure of methotrexate and hydroxychloroquine and sulfasalazine

- failure of Leflunomide

-> or equal to 18 years

- able to provide consent

- able to attend usual follow up visits

Exclusion Criteria:

- no contraindication to etanercept or tofacitinib

- active serious infection

- active Tuberculosis

- multiple sclerosis

- current cancer

- lymphoma ever

- previous use of an advanced therapeutic (biologic or JAK kinase inhibitor)

- less than 18 years of age

- unable to provide consent

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Etanercept

Drug: tofacitinib

Primary Outcome(s)

Retention Rates [Time Frame: 24 months]

Secondary Outcome(s)

Mean Change in Disease Activity [Time Frame: 24 months]

Secondary ID(s)

RAJP0001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Academic Medical Organization of Southwestern Ontario

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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