A Study of Clinical and Immune Responses to Sequential Biologic Therapies in Psoriatic Arthritis

NCT07417995 | Not Yet Recruiting FDA Drug

• 1 other identifier: 362489
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate how well advanced therapies work in adults with psoriatic arthritis (PsA) who are starting a biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) as part of routine care. The main questions are:

• Do treatment responses differ according to the number of previous advanced therapies?
• Can anti-drug antibodies (ADAs) or blood drug levels help predict treatment effectiveness? Researchers will compare participants receiving earlier-line versus later-line advanced therapies to assess differences in treatment response and antibody development. Participants will allow collection of routine clinical assessment data, complete questionnaires on symptoms and quality of life, and provide blood samples before treatment and at 12 weeks.

Conditions

Psoriasis Arthritis

Keywords

Anti-drug antibody; Biologic therapies; Immunogenicity; Targeted Synthetic DMARDs

Outcome Measures

Primary Outcomes (1)

• Clinical Disease Activity in Psoriatic Arthritis (cDAPSA)

  The cDAPSA is the primary outcome and is a validated composite measure of disease activity in PsA. It is calculated as the sum of the tender joint count (0-68 joints), swollen joint count (0-66 joints), patient global assessment of disease activity (0-10 cm visual analogue scale), and patient assessment of arthritis pain (0-10 cm VAS). Unlike the full DAPSA, cDAPSA does not include C-reactive protein. Scores provide a continuous measure of disease activity, with established thresholds to categorise disease states: remission (≤4), low disease activity (\>4-13), moderate disease activity (\>13-27), and high disease activity (\>27).

  Weeks 0/12

Secondary Outcomes (8)

• Body Surface Area of Psoriasis (BSA)

  Week 0/12

• Minimal Disease Activity (MDA)

  Weeks 0/12

• Psoriatic Arthritis Impact of Disease-9 (PsAID-9)

  Weeks 0/4/12/24/52

• Health Assessment Questionnaire-Disability Index (HAQ-DI)

  Weeks 0/4/12/24/52

• Patients' Global Assessment of Disease Activity (PGADA VAS)

  Weeks 0/4/12/24/52

Study Arms (4)

First-line Advanced Therapy

Participants with PsA initiating their first biologic or targeted synthetic disease-modifying antirheumatic drug (b/tsDMARD) as part of routine NHS clinical care. Treatment is prescribed by the treating clinician and not assigned by the study.

Drug: Biologic or targeted synthetic DMARD (b/tsDMARD)

Second/Third-line Advanced Therapy

Participants with PsA initiating a second or third b/tsDMARD following prior advanced therapy exposure. All treatments are part of routine clinical care.

Drug: Biologic or targeted synthetic DMARD (b/tsDMARD)

Fourth/Fifth-line Advanced Therapy

Participants with PsA initiating a fourth or fifth b/tsDMARD as part of routine care after multiple prior advanced therapy switches.

Drug: Biologic or targeted synthetic DMARD (b/tsDMARD)

Sixth-line or Later Advanced Therapy

Participants with PsA initiating a sixth or subsequent b/tsDMARD during routine clinical care.

Drug: Biologic or targeted synthetic DMARD (b/tsDMARD)

Interventions

Biologic or targeted synthetic DMARD (b/tsDMARD) DRUG

This is a non-interventional observational study. Participants will receive biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) as part of routine NHS clinical care, and no treatment will be assigned by the study. Participants will be categorised into cohorts according to the line of advanced therapy being initiated at study entry (first line, second/third line, fourth/fifth line, and sixth line or beyond). The study will evaluate treatment outcomes, circulating drug levels, and anti-drug antibody (ADA) status across these treatment-line groups. All treatment decisions remain at the discretion of the treating clinician.

First-line Advanced Therapy; Fourth/Fifth-line Advanced Therapy; Second/Third-line Advanced Therapy; Sixth-line or Later Advanced Therapy

Eligibility Criteria

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

Study Population

Adults with a confirmed diagnosis of PsA, meeting CASPAR classification criteria, who are initiating a new advanced therapy (b/tsDMARD) as part of routine NHS care.

You may qualify if:

• Age ≥18 years
• Clinical diagnosis of PsA meeting CASPAR criteria
• Starting a new b/tsDMARD, irrespective of line of therapy

You may not qualify if:

• Switching b/tsDMARD therapy for psoriasis or spondyloarthritis alone, without active psoriatic arthritis.
• Previous treatment with the same b/tsDMARD being started at baseline.
• Inability or unwillingness to provide informed consent.

Sponsors & Collaborators

• Royal United Hospitals Bath NHS Foundation Trust: lead
• University of Bath: collaborator

Study Sites (1)

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

Location

Related Publications (2)

• Gollins CE, Russell A, Smith T, Vivekanantham A, Brooke M, Coates LC, Gullick N, Helliwell P, McHugh N, Fahy C, Tillett W; SEQUENCE Study Group. A retrospective observational study of effectiveness of sequential biologic and targeted synthetic DMARDs in psoriatic arthritis in the UK. Rheumatology (Oxford). 2026 Feb 4;65(2):keaf570. doi: 10.1093/rheumatology/keaf570.

  PMID: 41206077 RESULT

• Gollins CE, Vincent R, Fahy C, McHugh N, Brooke M, Tillett W. Effectiveness of sequential lines of biologic and targeted small-molecule drugs in psoriatic arthritis: a systematic review. Rheumatology (Oxford). 2024 Jul 1;63(7):1790-1802. doi: 10.1093/rheumatology/keae006.

  PMID: 38243715 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum samples for anti-drug antibody and serum drug level testing

MeSH Terms

Interventions

Biological Products

Intervention Hierarchy (Ancestors)

Complex Mixtures

Study Officials

• James Kimpton, BA (Hons) BM BCh (oxon) MRCP

  Royal United Hospitals Bath NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Kimpton, BA (Hons) BM BCh (oxon) MRCP

CONTACT

+44 01225 824160; james.kimpton@nhs.net

Study Design

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

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: February 18, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-02

Locations

GB (1)