Tapering of Biologics in Inflammatory Arthritis Patients in Remission

NCT04429776 | Active Not Recruiting

• 1 other identifier: 281569
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

Rheumatoid arthritis (RA) and Psoriatic Arthritis (PsA) are types of inflammatory arthritis. They are disabling conditions caused by inflammation in joints that can lead to pain, stiffness, fatigue and joint damage. There is currently no cure but treatment is aimed at reducing joint inflammation. Some of the most promising new therapies work by interfering with the binding of a molecule called tumour necrosis factor (TNF). In recent years, new anti-TNF drugs (such as adalimumab, etanercept and certolizumab) have been developed that block the action of TNF and reduce this inflammation. These drugs are very effective in controlling inflammation for many patients whose arthritis has not responded to other therapies. Some patients can take these medications for a long time. If a patient is stable on their rheumatoid arthritis biologic or biosimilar, tapering the drug is often considered. The investigators are planning to look at drug level and anti-drug antibody testing to guide anti-TNF tapering (reducing) decisions in UK patients with RA who have stable, reduced arthritis symptoms. The investigators think that measuring these drug levels and anti-drug antibodies in blood samples will be useful for guiding this process, but the investigators can't be sure. It is important to do this safely so the patient doesn't experience a flare of their disease symptoms. The study will be used to determine whether a much larger study to assess the usefulness of these measurements would be achievable. This study will assess whether measuring biomarkers (measurable substances in the blood) that may affect a patient's response to treatment. If a patient are eligible to take part, they will be randomly allocated to one of the following groups;

• Their Doctor receiving information and treatment advice based on their blood results or
• Their Doctor not receiving this information

Conditions

Rheumatoid Arthritis; Psoriatic Arthritis

Outcome Measures

Primary Outcomes (1)

• Time to flare

  Time to flare

  3 years

Secondary Outcomes (5)

• Successful recruitment

  3 years

• Was biologic advice, provided in the protocol, adopted by clinicians and participants?

  3 years

• Participant withdrawal rate

  3 years

• Participant acceptability, via the feedback form

  3 years

• Participant reported outcome measures recorded in the participant questionnaire booklet.

  3 years

Study Arms (2)

Feedback Arm

EXPERIMENTAL

Trough blood samples taken and analysed at baseline, 6m and 12m. Results fed back to recruiting clinical team who can choose to use these to influence their tapering decisions.

Diagnostic Test: Drug level testing with feedback provided

No Feedback Arm

ACTIVE COMPARATOR

Trough blood samples taken and analysed at baseline, 6m and 12m. Results not fed back to recruiting clinical team.

Diagnostic Test: Drug level testing with no feedback provided

Interventions

Drug level testing with feedback provided DIAGNOSTIC_TEST

Feedback about drug levels in blood provided to participant's site

Also known as: Anti-drug antibody testing

Feedback Arm

Drug level testing with no feedback provided DIAGNOSTIC_TEST

Testing drug levels in blood but feedback not provided to participant's site

Also known as: Anti-drug antibody testing

No Feedback Arm

Eligibility Criteria

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

You may qualify if:

• Patients must have RA according to the American College of Rheumatology (ACR) 1987 or 2010 criteria
• Patients must be willing and able to participate in the study (including follow up visits and providing blood samples) after providing informed consent.
• Patients must currently be on stable treatment a one of the following single anti-TNF agents Adalimumab, Etanercept or Certolizumab. They must have been taking this biologic/ biosimilar therapy for a minimum of 12 months
• Patients must be in remission with a DAS28 CRP of less than or equal to 2.6.
• A DAS28 score must be provided at baseline. This must have been taken within the month before study recruitment. If this DAS score is not available, the patient is not eligible to take part.
• Consultant must be looking to taper patient's standard care medication
• Aged 18 years or over

You may not qualify if:

• Anyone who has switched anti-TNF agent in the last 12 months
• Anyone without a recent DAS score (within the previous month)
• Anyone taking any anti-TNF therapy that isn't Adalimumab, Etanercept or Certolizumab.
• Anyone who has received steroids within past 3 months (enteral, parenteral or intra-articular)
• Anyone who is currently pregnancy, or pregnancy planned within next 6 months
• Anyone with any planned major surgery
• Anyone with the inability to provide informed consent

Sponsors & Collaborators

• University of Manchester: lead

Study Sites (1)

Manchester University Hospitals NHS Foundation Trust

Manchester, North West, M13 9WL, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis, Psoriatic

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin 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: Clinical Professor of Rheumatology

Model Details: 50 Participants: randomised 1:1 to either feedback of test results to treating clinician or no feedback to treating clinician (25 participants each arm)

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 12, 2020
• Study Start: May 13, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 10, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)