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T Cells and TNF (Tumor Necrosis Factor): The Impact of TNF Blockade

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01060098
Recruitment Status : Completed
First Posted : February 2, 2010
Results First Posted : January 2, 2020
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Study Description
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Brief Summary:
We aim to translate these findings into patients with rheumatoid arthritis and other conditions treated with anti-TNF (anti-tumor necrosis factor) therapy, such as psoriatic arthritis and ankylosing spondylitis. Patients from rheumatology clinics within NHS (National Health Service) trusts will be recruited. We will correlate disease activity assessed by clinical parameters, ultrasonography, and questionnaires with biomarkers in the blood and target tissues, such as synovium and skin.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Drug: anti-TNF therapy (etanercept or adalimumab)

Detailed Description:
Inflammatory arthritis particularly rheumatoid arthritis (RA), psoriatic arthritis and ankylosing spondylitis are potentially disabling conditions which cause joint pain, swelling and deformity and treatments are aimed at preventing these complications. Although treatment has improved with the advent of anti TNF alpha therapies, up to 30% of patients fail to respond to this treatment and in others, treatment is associated with significant side effects. The precise mechanisms of this remain unclear. In addition, there are no sensitive methods available to monitor or predict disease response to treatment aside from testing inflammatory markers in the blood. Understanding the mechanism of action and what governs response to anti TNF therapy will allow development of more specific therapies for inflammatory arthritis. Work in animal models of rheumatoid arthritis has characterised a novel cell type, Th17 cells, important in the inflammatory cascade which are affected in a particular way by anti TNF therapies and may underpin their mechanism of action and side effects.
Study Design
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Study Type : Observational
Actual Enrollment : 48 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: T Cells and TNF: The Impact of TNF Blockade on Effector T Cell Populations in Rheumatoid Arthritis and Other Conditions Treated With Anti-TNFalpha Agents
Actual Study Start Date : April 2010
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Rheumatoid arthritis
Participants with Rheumatoid arthritis
 Drug: anti-TNF therapy (etanercept or adalimumab)
Biological DMARD
Other Names:
  • Enbrel
  • Humira
Ankylosing spondylitis
Participants with Ankylosing spondylitis
 Drug: anti-TNF therapy (etanercept or adalimumab)
Biological DMARD
Other Names:
  • Enbrel
  • Humira
Psoriatic arthritis
Participants with Psoriatic arthritis
 Drug: anti-TNF therapy (etanercept or adalimumab)
Biological DMARD
Other Names:
  • Enbrel
  • Humira


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of Effector T Helper Type 17 Cells in Peripheral Blood [ Time Frame: Week 0, Week 12 ]
    The frequency of circulating Th17 cells was determined by IL17 enzyme-linked immunospot assay (Elispot) and flow cytometry (fluorescence-activated cell sorting (FACS)).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic
Criteria

Inclusion criteria:

  • Only anti-TNF naïve patients will be included in this study
  • Patients between 18 to 80 years of age
  • Patients due to start treatment with anti-TNF blocking agents - etanercept or adalimumab

Patients with rheumatoid arthritis

  • Only patients meeting the 1987 American College of Rheumatology (ACR) revised classification criteria for rheumatoid arthritis will be included
  • Patients should have active rheumatoid arthritis, defined by an initial DAS28 score >5.1
  • Patients should have at least 1 joint suitable for synovial biopsy
  • Patients can be on concurrent DMARDs but they should have been on a stable dose of DMARD for at least 1 month prior to study entry
  • Patients can be on a concurrent dose of glucocorticoids (up to 10mg daily) and they should have been on a stable dose for at least 4 weeks prior to study entry

Patients with psoriatic arthritis

  • Patients should have a secure diagnosis of psoriatic arthritis determined by a rheumatologist
  • Patients with psoriatic arthritis included in this study should have evidence of concurrent psoriatic skin lesions at the time of study entry
  • Patients should have at least one joint suitable for synovial biopsy
  • Patients can be on concurrent DMARDs - they should be on a stable dose of DMARD for at least 1 month prior to study entry

Patients with Ankylosing spondylitis

  • Patient should fulfil the Modified New York Criteria for diagnosis of ankylosing spondylitis
  • Patients can be on concurrent NSAIDs
  • Patients can be on concurrent DMARDs - they should be on a stable dose of DMARD for at least 1 month prior to study entry

Exclusion Criteria:

  • Patients who have been previously treated with anti-TNF therapy for whatever reason
  • Patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who do not fulfil the diagnostic criteria for these conditions as above
  • Patient who have received an intra-articular injection of steroids or have received an intra-muscular injection of depot steroid to treat disease flare in the preceding 4 weeks prior to commencing anti-TNF therapy.
  • Patients with intercurrent, active infection of any type, excluding the common cold
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01060098


Locations
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United Kingdom
Kennedy Institute Clinical Trials Unit, 4Wl, Charing Cross Hospital
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Sonya Abraham Imperial College London
More Information
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Publications of Results:

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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01060098    
Other Study ID Numbers: 2104091
First Posted: February 2, 2010    Key Record Dates
Results First Posted: January 2, 2020
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Rheumatoid arthritis
Additional relevant MeSH terms:
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Spondylitis
Arthritis
Arthritis, Rheumatoid
Arthritis, Psoriatic
Spondylitis, Ankylosing
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
Bone Diseases
 Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Bone Diseases, Infectious
Infections
Ankylosis
Adalimumab
Etanercept
Anti-Inflammatory Agents
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents