Dose reduction and withdrawal of biological therapy in patients with rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis: Protocol for a 18 months multi-centre trial

Phase 1

• Conditions: Rheumatoid arthritis, psoriatic arthritis and axial spondyloarthritis; MedDRA version: 21.0 Level: LLT Classification code 10040107 Term: Seropositive rheumatoid arthritis System Organ Class: 100000004859; MedDRA version: 21.0 Level: LLT Classification code 10062719 Term: Seronegative rheumatoid arthritis System Organ Class: 100000004859; MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859; MedDRA version: 20.0 Level: LLT Classification code 10076297 Term: Non-radiographic axial spondyloarthritis System Organ Class: 100000004859; MedDRA version: 21.1 Level: LLT Classification code 10041672 Term: Spondylitis ankylosing System Organ Class: 100000004859; MedDRA version: 20.0 Level: LLT Classification code 10002557 Term: Ankylosing spondylitis and other inflammatory spondylopathies System Organ Class: 100000004859; MedDRA version: 21.0 Level: LLT Classification code 10045966 Term: Unspecified inflammatory spondylopathy System Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2017-001970-41-DK
• Lead Sponsor: MD, PhD Salome Kristensen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-09-15
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

A participant will be eligible for trial participation if he/she meets the following criteria:
- The participant is able and willing to provide written informed consent and comply with the requirements of this trial protocol.
- The participant is = 18 years of age
- Meets the diagnostic criteria for rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis as specified in the protocol.
- Participants must be treated with abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab or tocilizumab in stable dose (i.e. standard dose or reduced dose) during the last 12 months
- Participants must be in sustained clinical remission/LDA as defined in this protocol during the last 12 months measured by = 2 registrations in the Danish Rheumatology Database (DANBIO)
- Female participants with childbearing potential: negative pregnancy test at baseline and practicing safe birth control as described in the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

A participant cannot be included in the trial if he/she meets any of the following criteria:
- Inability to provide informed consent or unwilling to comply with the trial protocol
- Current oral prednisolone treatment
- Intra-articular or parenteral administration of corticosteroids or a short course of oral prednisolone within the last year
- Dose reduction of the biological therapy is not suitable judged by medical expert assessment due to e.g. patients with previously severe arthritis with difficult to reach remission on biological therapy or patients who previously have tried dose reduction of the biological therapy resulting in flare
- Female participants who is pregnant or breast-feeding or considering becoming pregnant while on biological therapy, MTX and/or leflunomide or within 3-6 months after the last dose
- Participants who have a history of psychiatric or psychological conditions that, in the opinion of the investigator, will affect the ability to participate in the trial
- Addictive or previous addictive behaviour defined as abuse of alcohol, hash, opioids or other euphoric substances
- Participants who is considered an unsuitable candidate for the trial for any reason by the in-vestigator
Allergic reaction or significant sensitivity to constituents of the study drugs are not considered a relevant exclusion criterion in this trial as patients have been treated with the study drugs (biological therapy) > 1 year prior to inclusion.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified