Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid Arthritis

• Register: ClinicalTrials.gov
• Last refreshed on: 31 August 2015
• Main ID: NCT02528292
• Date of registration: 05/08/2011
• Prospective Registration: No
• Primary sponsor: Barts & The London NHS Trust
• Public title: Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Rheumatoid Arthritis
• Scientific title: Phase 4 Study of Clinical Disease Activity and Modulation of Synovial Lymphoid Structures and B Cell Function in Patients With Rheumatoid Arthritis Undergoing Treatment With Anti-TNF Therapy
• Date of first enrolment: October 2010
• Target sample size: 24
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02528292
• Study type: Observational
• Study design: Observational Model: Cohort, Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Costantino Pitzalis, MD, PhD
• Affiliation: Barts and the London NHS Trust

Key inclusion & exclusion criteria

Inclusion Criteria:

- Men and women = 18 and = 75 years of age, with RA as defined by the 1987 revised ACR
classification criteria.

- Patients must fulfill the National Institute for Clinical Excellence guidelines for
TNF Blocking Therapy in RA.

- Patients must be on MTX for at least 4 months, with a stable dose of 7.525 mg/week
for a minimum of 4 weeks.

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

- Patients must be able to adhere to the study visit schedule.

- Patients must be capable of giving informed consent and the consent must be obtained
prior to any screening procedures.

- Must have a chest Xray within 3 months prior to commencement of antiTNFa with no
evidence of malignancy, infection or fibrosis.

Exclusion Criteria:

- Women who are pregnant or breast feeding.

- Use of any investigational drug within 1 month prior to screening or within 5
half-lives of the investigational agent, whichever is longer.

- Previous use of antiTNF biologics.

- Treatment with any other therapeutic agent targeted at reducing TNF (eg,
pentoxifylline, thalidomide, etc.) within 3 months of screening.

- Serious infections (such as, HIV, HBV, 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.

- Have active TB or have evidence of latent TB (old or latent TB on chest Xray, without
adequate therapy for TB initiated prior to first dose of study drug). Also excluded
are patients with evidence of an old or latent TB infection without documented
adequate therapy.

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

- 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).

- 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,
infraclavicular, epitrochlear, or periaortic areas), or splenomegaly.

- Known recent substance abuse (drug or alcohol).

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



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Procedure: Synovial biopsy

Drug: Anti-TNF therapy

Primary Outcome(s)

Correlation of change in synovial ectopic lymphoneogenesis with EULAR response criteria using DAS28 [Time Frame: Baseline and 12 months]

Secondary Outcome(s)

Disability and health status assessed using the HAQ questionnaire [Time Frame: Baseline and 12 months]

Change in synovial histomorphology with treatment [Time Frame: baseline and 3 months]

X-ray progression [Time Frame: Baseline and 12 months]

Correlation of peripheral blood lymphocytes including, Treg markers and, B cell subsets [Time Frame: baseline and 12 months]

Secondary ID(s)

UCB-007275

Source(s) of Monetary Support

Please refer to primary and secondary sponsors