Research into injecting golimumab less frequently by using increased doses

Phase 1

• Conditions: rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis; MedDRA version: 21.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 21.1 Level: PT Classification code 10071400 Term: Axial spondyloarthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2019-004101-27-NL
• Lead Sponsor: Sint Maartenskliniek

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-12-12
• Last Update Posted: 1 February 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 35

Inclusion Criteria

•Rheumatoid arthritis, psoriatic arthritis or axial spondyloarthritis by fulfilling one of the following:
oRheumatoid arthritis: either 2010 ACR RA13 and/or 1987 RA14 criteria and/or clinical diagnosis of the treating rheumatologist;
oPsoriatic arthritis: Classification Criteria for Psoriatic Arthritis (CASPAR)15 and/or diagnosed with peripheral SpA of the psoriatic arthritis subtype by a rheumatologist;
oAxial spondyloarthritis: Assessment of SpondyloArthritis international Society (ASAS) classification criteria16 and/or clinical diagnosis of the treating rheuma-tologist;
•Patients using golimumab in the standard dose of 50mg every month for at least three months with a good clinical response, defined as DAS28-CRP = 2.6 for RA, or PASDAS = 3.2 (PsA) or ASDAS < 2.1;
•Patient informed consent, =16 years old and mentally competent;
•Ability to measure the outcome of the study in this patient (e.g. patient availability; willing and being able to undergo repeated serum samples);
•Ability to read and communicate well in Dutch.
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 35
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnancy

Study & Design

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