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

NCT01060098 | Completed Results

• 1 other identifier: 2104091
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis; Psoriatic Arthritis

Keywords

Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Measurement of Effector T Helper Type 17 Cells in Peripheral Blood

  The frequency of circulating Th17 cells was determined by IL17 enzyme-linked immunospot assay (Elispot) and flow cytometry (fluorescence-activated cell sorting (FACS)).

  Week 0, Week 12

Study Arms (3)

Rheumatoid arthritis

Participants with Rheumatoid arthritis

Drug: anti-TNF therapy (etanercept or adalimumab)

Ankylosing spondylitis

Participants with Ankylosing spondylitis

Drug: anti-TNF therapy (etanercept or adalimumab)

Psoriatic arthritis

Participants with Psoriatic arthritis

Drug: anti-TNF therapy (etanercept or adalimumab)

Interventions

anti-TNF therapy (etanercept or adalimumab) DRUG

Biological DMARD

Also known as: Enbrel, Humira

Ankylosing spondylitis; Psoriatic arthritis; Rheumatoid arthritis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Kennedy Institute Clinical Trials Unit, 4Wl, Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (2)

• Hull DN, Cooksley H, Chokshi S, Williams RO, Abraham S, Taylor PC. Increase in circulating Th17 cells during anti-TNF therapy is associated with ultrasonographic improvement of synovitis in rheumatoid arthritis. Arthritis Res Ther. 2016 Dec 23;18(1):303. doi: 10.1186/s13075-016-1197-5.

  PMID: 28010726 RESULT

• Hull DN, Williams RO, Pathan E, Alzabin S, Abraham S, Taylor PC. Anti-tumour necrosis factor treatment increases circulating T helper type 17 cells similarly in different types of inflammatory arthritis. Clin Exp Immunol. 2015 Sep;181(3):401-6. doi: 10.1111/cei.12626. Epub 2015 Jun 23.

  PMID: 25766640 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing; Arthritis, Psoriatic

Interventions

Etanercept; Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies

Results Point of Contact

• Title: Sonya Abraham
• Organization: Imperial College London

s.abraham@imperial.ac.uk

+44 (0)20 3313 4114

Study Officials

• Sonya Abraham

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 2, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 18, 2020
• Results First Posted: January 2, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)