BIOTIPRA: BIOmarker-guided Treatment Decisions In Psoriatic and Rheumatoid Arthritis

NCT03853395 | Completed DMC

• 1 other identifier: NHS001481
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 9

Brief Summary

TNFi drugs remain the most prescribed first-line biologics for patients with rheumatoid arthritis (RA). However, up to 40% of RA patients fail to respond to TNFi treatment. One explanation of non-response is the development of anti-drug antibodies and low drug levels. Studies have consistently shown that:

1. 1.Serum drug levels of monoclonal antibodies (such as adalimumab, certolizumab, infliximab) and the presence of anti-drug antibodies in samples taken at 3 and 6 months correlate with subsequent response at 12 months.
2. 2.Non-responders and those who develop anti-drug antibodies are less likely to receive concomitant methotrexate or, if they do receive it, are on lower doses than responder groups.

Conditions

Arthritis, Rheumatoid

Outcome Measures

Primary Outcomes (4)

• 1. Power for full randomised controlled trial: Change in Disease Activity Score (DAS)-28 over 12 months

  through study completion, an average of 1 year

• 2. Process evaluation: Patient/care-giver opinion of measuring adalimumab/certolizumab drug levels and anti-drug antibodies with feedback using a specially adapted questionnaire

  through study completion, an average of 1 year

• 3. Process evaluation: Patient and care-giver opinion of process of research, including outcome measures measured by a specially adapted questionnaire

  through study completion, an average of 1 year

• 4. Process evaluation: fidelity and quality of trial implementation and success of recruitment strategy

  A mixed-methods process evaluation will explore the fidelity and quality of implementation through evaluation of missing and non-missing responses. To inform the decision to proceed to a full clinical trial evaluation will take place measuring intervention fidelity; recruitment time; uptake; patient acceptability; withdrawal rate; effect size; affordability; study period required; time required for drug measurement and patient perspectives.

  through study completion, an average of 1 year

Secondary Outcomes (8)

• 1. Change in Health Assessment Questionnaire (HAQ) measurement

  through study completion, an average of 1 year

• 2. Change in Short Form 36 (SF-36)

  through study completion, an average of 1 year

• 3. Change in SF-36 vitality subscale

  through study completion, an average of 1 year

• 4. Health Assessment Questionnaire Disability Index at 12 months

  through study completion, an average of 1 year

• 5. Change in pain Visual Analog Scale (VAS)

  through study completion, an average of 1 year

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Participants on this arm of the study will provide trough blood samples and complete participant questionnaires. Their research teams will return clinical information about them to the University of Manchester. Clinicians for this group of participants will not receive blood results (about drug levels or anti-drug antibodies) or treatment advice from the University of Manchester about their participant.

Diagnostic Test: Tests for drug levels and anti-drug antibodies

Experimental Arm

EXPERIMENTAL

Participants on this arm of the study will provide trough blood samples and complete participant questionnaires. Their research teams will return clinical information about them to the University of Manchester. Clinicians for this group of participants will receive blood results (about drug levels or anti-drug antibodies) or treatment advice from the University of Manchester about their participant. They will be able to act accordingly.

Diagnostic Test: Tests for drug levels and anti-drug antibodies

Interventions

Tests for drug levels and anti-drug antibodies DIAGNOSTIC_TEST

Measurement of drug levels and anti-drug antibodies will be undertaken using commercially available enzyme-linked immunosorbent assays (ELISAs) and/or radioimmunoassays

Control Arm; Experimental Arm

Eligibility Criteria

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

You may qualify if:

• Patients with RA about to start therapy with adalimumab or certolizumab
• Age 18 and over, male or female
• Willing to take part in the study
• Patients who consent to take part in the BRAGGSS study

You may not qualify if:

• Patients unwilling or unable to take part in the study
• Pregnant women or nursing (breast feeding) mothers.
• Planned pregnancy within next 12 months.
• Scheduled surgery in the next 12 months or other pre-planned reasons for treatment discontinuation in the next 12 months.
• Contraindication to adalimumab or certolizumab according to the summary of product characteristics

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (9)

Centre for Musculoskeletal Research

Manchester, England, M13 9PT, United Kingdom

Location

Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hampshire, RG24 9NA, United Kingdom

Location

Midlands Partnership NHS Foundation Trust

Stafford, Staffordshire, ST16 3AG, United Kingdom

Location

Leicester Royal Infirmary

Leicester, LE1 5WW, United Kingdom

Location

Homerton University Hospital NHS Foundation Trust

London, E9 6SR, United Kingdom

Location

Manchester University Hospitals NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

Location

Northern Care Alliance NHS Group

Manchester, M5 5AP, United Kingdom

Location

Torbay and South Devon NHS Foundation Trust

Torquay, TQ2 7AA, United Kingdom

Location

Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Investigator

Study Record Dates

• First Submitted: February 21, 2019
• First Posted: February 25, 2019
• Study Start: May 31, 2019
• Primary Completion: May 7, 2025
• Study Completion: May 7, 2025
• Last Updated: May 11, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9)