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

Study Purpose

TNFi drugs remain the most prescribed first-line biologics for patients with rheumatoid arthritis (RA) and Psoriatic Arthritis (PsA). 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. Drug levels of monoclonal antibodies (e.g. adalimumab/certolizumab) and the presence of anti-drug antibodies in samples taken at 3 and 6 months correlate with 12 month response. 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. However, it has not been proven that knowing that a patient has low drug levels or anti-drug antibodies improves the outcome; neither has it been shown that introducing or increasing the dose of methotrexate would reduce the formation of anti-drug antibodies, thereby improving outcome. Observational data has revealed that RA non-responders, who exhibit adequate serum drug levels and no detectable anti-drug antibodies, have lower probability of response to another agent with the same mechanism of action (MOA). RA and PsA non-responders, who have low detectable serum trough levels and detectable anti-drug antibodies, may benefit in switching to a less immunogenic drug. The next essential step, therefore, is to prove that introducing these tests improves clinical outcome. The proposed trial is a clinical feasibility trial with the aim to ensure a realistic assessment and capability to conduct the full clinical trial. Participants with RA or PsA, commencing adalimumab or certolizumab will be randomised to determine whether providing test results on trough drug levels and anti-drug antibodies at 4 weeks, 3 and 6 months to clinicians caring for patients with RA or PsA (n=15 patients) starting treatment with adalimumab/certolizumab, improves the course of disease activity, compared to standard care (n=15 patients). Clinicians will be provided with feedback and a treatment algorithm. The feasibility of the study will be assessed by a number of factors including evaluation of recruitment, attrition, data completeness and process evaluation.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients with RA or PsA about to start therapy with adalimumab or certolizumab (n = 30 total) 2. Age 18 and over, male or female. 3. Willing to take part in the study. 4. Patients who are taking part in either the BRAGGSS or OUTPASS study
  • -

    Exclusion Criteria:

    1.
Patients unwilling or unable to take part in the study. 2. Pregnant women or nursing (breast feeding) mothers. 3. Planned pregnancy within next 12 months. 4. Scheduled surgery in the next 12 months or other pre-planned reasons for treatment discontinuation in the next 12 months. 5. Contraindication to adalimumab or certolizumab according to the summary of product characteristics -

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03853395
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Manchester
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United Kingdom
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Arthritis, Rheumatoid, Arthritis, Psoriatic
Arms & Interventions

Arms

Active Comparator: Control Arm

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.

Experimental: Experimental Arm

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.

Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Centre for Musculoskeletal Research, Manchester, England, United Kingdom

Status

Not yet recruiting

Address

Centre for Musculoskeletal Research

Manchester, England, M13 9PT

Site Contact

Sarah L Ashton, BSc

[email protected]

+44 (0)161 306 0539

Hampshire Hospitals NHS Foundation Trust, Basingstoke, Hampshire, United Kingdom

Status

Recruiting

Address

Hampshire Hospitals NHS Foundation Trust

Basingstoke, Hampshire, RG24 9NA

Site Contact

Chris Graver

[email protected]

01256 314002

Stafford, Staffordshire, United Kingdom

Status

Not yet recruiting

Address

Midlands Partnership NHS Foundation Trust

Stafford, Staffordshire, ST16 3AG

Site Contact

Chantel-lea Grocott

[email protected]

01785 783180

Leicester Royal Infirmary, Leicester, United Kingdom

Status

Recruiting

Address

Leicester Royal Infirmary

Leicester, , LE1 5WW

Site Contact

Louise Boyles

[email protected]

0116 2586772

London, United Kingdom

Status

Recruiting

Address

Homerton University Hospital NHS Foundation Trust

London, , E9 6SR

Site Contact

Cate Holbrook

[email protected]

0208 510 7412

Manchester, United Kingdom

Status

Recruiting

Address

Manchester University Hospitals NHS Foundation Trust

Manchester, , M13 9WL

Site Contact

JoAnn Nicolson

[email protected]

0161 701 8538

Northern Care Alliance NHS Group, Manchester, United Kingdom

Status

Recruiting

Address

Northern Care Alliance NHS Group

Manchester, , M5 5AP

Site Contact

Lorraine Lock

[email protected]

0161 778 2634

Torquay, United Kingdom

Status

Active, not recruiting

Address

Torbay and South Devon NHS Foundation Trust

Torquay, , TQ2 7AA

Royal Wolverhampton NHS Trust, Wolverhampton, United Kingdom

Status

Not yet recruiting

Address

Royal Wolverhampton NHS Trust

Wolverhampton, , WV10 0QP

Site Contact

Julie Edwards

[email protected]

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