Adult patients with a diagnosis of Psoriatic Arthritis(PsA), (Caspar criteria) of less than 24-month duration.
Conditions
Interventions
Trade Name: SIMPONI
Product Name: Golimumab pre-filled syringe
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: Golimumab
CAS Number: 476181-74-5
Other descripti
Sponsors
The Leeds Teaching Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to assess the feasibility of running a clinical trial comparing the efficacy of a treatment strategy in early, treatment naïve PsA patients, using a combination of early TNFi therapy (Golimumab) plus methotrexate plus steroids versus standard care (MTX monotherapy plus steroids) using WB-MRI as an outcome measure. ;Secondary Objective: • Number (%) of subjects achieving MDA. • Number (%) of subjects achieving PsARC, ACR responses and PASDAS disease activity response criteria. • Relationship of clinical and imaging (WB-MRI and US) response to the total amount of steroids received by week 12. • Relationship between clinical and imaging response and number of swollen and tender joints at baseline. • Relationship between clinical response and duration of symptoms at time of presentation. • Radiologic outcomes for golimumab + MTX vs MTX monotherapy over a 52 week period in terms of WB-MRI (24 and 36 weeks) and ultrasound assessment of disease activity and joint damage and radiographic joint damage (x-rays). • Predictors of early response in terms of WB-MRI and ultrasound over a 12 week period. • Predictors of sustained response in terms of ultrasound over a 52 week period. • Impact of both treatment strategies in quality of life patient reported outcomes (PsAQoL, EQ-5D, SF-36, DLQI). • To determine whether c;Primary end point(s): Number of joints/entheses with inflammatory lesions on WB-MRI (bone marrow oedema/osteitis and/or synovitis) present at 24 weeks.;Timepoint(s) of evaluation of this end point: September 2015 - September 2016 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number (%) of subjects achieving MDA. Number (%) of subjects achieving PsARC, ACR responses and PASDAS disease activity response criteria. Relationship of clinical and imaging (WB-MRI and US) response to the total amount of steroids received by week 12. Relationship between clinical and imaging response and number of swollen and tender joints at baseline. Relationship between clinical response and duration of symptoms at time of presentation. Radiologic outcomes for golimumab + MTX vs MTX monotherapy over a 52 week period in terms of WB-MRI (24 and 36 weeks) and ultrasound assessment of disease activity and joint damage and radiographic joint damage (x-rays). Predictors of early response in terms of WB-MRI and ultrasound over a 12 week period. Predictors of sustained response in terms of ultrasound over a 52 week period. Impact of both treatment strategies in quality of life patient reported outcomes (PsAQoL, EQ-5D, SF-36, DLQI). To determine whether clinical response is associated with evidence of immunological normalisation, by evaluating changes in immunological markers of inflammation between baseline and weeks 12, 24, 36 and 52. ;Timepoint(s) of evaluation of this end point: September 2015 - September 2016 | — |
Countries
United Kingdom
Contacts
Public ContactMark Harrison
The Leeds Teaching Hospitals NHS Trust
Outcome results
None listed