Th17 Responses Evaluated in RA Patients on Inhibitors of TNFa

• Register: ClinicalTrials.gov
• Last refreshed on: 3 October 2022
• Main ID: NCT02620189
• Date of registration: 12/10/2015
• Prospective Registration: No
• Primary sponsor: Queen Mary University of London
• Public title: Th17 Responses Evaluated in RA Patients on Inhibitors of TNFa THERAPIST
• Scientific title: A Study to Investigate the Role of IL-17 and Th17 Pathway Activation in RA Patients With Inadequate Response to Anti-TNFa Therapies
• Date of first enrolment: March 2015
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02620189
• Study type: Observational

Countries of recruitment

United Kingdom

Contacts

• Name: Costantino Pitzalis, MD PhD FRCP
• Affiliation: Queen Mary University of London

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Men and women = 18 years of age

2. An RA diagnosis as defined by the 2010 revised EULAR/ACR classification criteria.

3. Subjects who fulfil the NICE guidelines for Biologic therapy as their first line
treatment following failure of standard disease modifying anti-rheumatic therapy.

4. Subjects may be on cDMARDs (or MTX monotherapy) one of which must be MTX. Participants
should be receiving MTX for at least 2 months at a stable dose of 7.5-25 mg/week
before Week 0 visit.

5. Subjects may be on oral steroids (prednisone =10 mg/day, or equivalent corticosteroid)
with a stable dose for the 4 weeks prior to Week 0 visit.

6. Men and women of childbearing potential must use adequate birth control measures
(e.g., abstinence, oral contraceptives, intrauterine device, barrier method with
spermicide, or surgical sterilization) for the duration of the study.

7. Participants must be able to adhere to the study visit schedule.

8. The participant must be capable of giving informed consent and the consent must be
obtained prior to any screening procedures.

9. Must have a chest X-ray within 6 months prior to commencement of anti-TNF therapy with
no evidence of malignancy, infection or fibrosis.

Exclusion Criteria:

Participants will be excluded from this study for any of the following reasons:

1. Women who are pregnant or breast feeding.

2. Previous use of Rheumatoid Arthritis anti-TNF biologics, or ANY other type of biologic
therapy or Investigational Medicinal Product.

3. Treatment with any other therapeutic agent targeted at reducing TNF within 3 months of
screening.

4. Serious infections (such as pneumonia or pyelonephritis) in the previous 3 months.
Less serious infections (such as acute upper respiratory tract infection [colds] or
simple urinary tract infection) need not be considered exclusions at the discretion of
the investigator.

5. Known HIV, Hepatitis B, or Hepatitis C infection.

6. Have active TB or have evidence of latent TB (old or latent TB on chest x-ray, without
adequate therapy for TB initiated prior to first dose of study drug). Participants
with a current close contact with an individual with active TB and participants who
have completed treatment for active TB within the previous 2 years are explicitly
excluded from the trial. Participants with a household member who has a history of
active pulmonary TB should have had a thorough evaluation for TB prior to study
enrolment as recommended by a local infectious disease specialist or published local
guidelines of TB control agencies.

7. Presence of a transplanted organ (with the exception of a corneal transplant >3 months
prior to screening).

8. Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the
skin that has been treated with no evidence of recurrence).

9. History of lymphoproliferative disease including lymphoma, or signs and symptoms
suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual
size or location (such as nodes in the posterior triangle of the neck,
infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.

10. Known recent substance abuse (drug or alcohol).

11. Poor tolerability of venepuncture required blood sampling during the study period.

12. Planning to have surgery for RA or other significant surgery during the period of the
study.



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Anti-TNF Biologics Therapy

Primary Outcome(s)

Measure change in clinical response using Disease Activity Score DAS28 (C-Reactive Protein) at week 24 compared to baseline [Time Frame: Baseline and week 24]

Secondary Outcome(s)

Change in Interleukin (IL)-17/T helper (Th)17 pathway activity in responders and non-responders to anti-Tumour Necrosis Factor (TNF) therapy [Time Frame: Baseline and week 24]

Secondary ID(s)

009745

Source(s) of Monetary Support

Please refer to primary and secondary sponsors