GOLMePsA

Phase 1

• Conditions: Adult patients with a diagnosis of Psoriatic Arthritis(PsA), (Caspar criteria) of less than 24-month duration.; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-004122-28-GB
• Lead Sponsor: The Leeds Teaching Hospitals NHS Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-22
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

1.Male and female patients aged =18 years at the time of signing the Informed Consent Form.
2.Subjects with a diagnosis of psoriatic arthritis as per the Classification for Psoriatic Arthritis (CASPAR) criteria (Appendix 4) confirmed less than 24 months prior to screening.
3.Subjects with active PsA defined as the presence of at least 3/68 tender and at least 3/66 swollen joints or 2 swollen and 2 tender joints plus one affected entheseal site (Achilles tendon and/or plantar fascia) at baseline.
4.Subjects should have one or more active inflammatory lesions (bone marrow oedema/osteitis/enthesitis or synovitis) on WB-MRI at baseline.
5.Are treatment naïve to DMARDs.
6.Are capable of understanding and signing an informed consent form.
7.Women of childbearing potential or men capable of fathering children must be using adequate birth control measures (eg, abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, surgical sterilization) during the study and for 6 months after receiving the last administration of study agent. Female subjects of childbearing potential must test negative for pregnancy. Female subjects must agree to not donate eggs (ova, oocytes) during the study and for 6 months after last dose of study agent. Male subjects must agree to not donate sperm while in the study and for 6 months after last dose of study agent.
8.Patients fulfilling the following TB criteria:
8.1.Have no history of latent or active TB prior to screening. An exception is made for subjects with a history of latent TB and documentation of having completed appropriate treatment for latent TB 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
8.2.Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
8.3.Have had no close contact with a person with active TB or, if there has been such a contact, will be referred to a physician specializing in TB to undergo additional evaluation, and if warranted, receive appropriate treatment as if having latent TB prior to or simultaneously with the first administration of study agent.
8.4.Within 6 weeks prior to the administration of study agent, either have a negative QuantiFERON-TB Gold test result or have a newly identified positive QuantiFERON-TB Gold test result in which active TB has been ruled out and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent.
8.5.In the event of 2 inderterminate QuantiFERON-TB Gold in-tube tests results, the subjects will be treated as if having latent TB prior or simultaneously with the first administration of study agent.
8.6.Have a chest radiograph (posterior-anterior view), read by a qualified radiologist, whose diagnostic assessment is consistent with no evidence of current active TB or old inactive TB, and taken within 12 months of the study.
8.7.Have a screening laboratory test result as follows:
8.7.1.Hb=8.5 g/dL or =5.3 mmol/L
8.7.2.White blood cell (WBC) count =3.5x103 cells/uL
8.7.3.Neutrophils =1.5 x103 cells/uL
8.7.4.Platelets =100x103 cells/uL
8.7.5.Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels not exceeding 1.5 times the upper limit of normal (UKN) for the central laboratory conducting the test.
8

Exclusion Criteria

1.Received previous treatment with any DMARDs.
2.Received previous treatment with Golimumab or other tumour necrosis factor inhibitor (TNFi) or other biologic drugs.
3.Any chronic inflammatory arthritis diagnosed before 16 years old.

Study & Design

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