None listed
Conditions
Brief summary
This study is designed to assess the rate of response to treatment (subcutaneous golimumab 50mg given four weekly) on MRI and other clinical RA measures in 12 participants diagnosed with active rheumatoid arthritis with inadequate response to Methotrexate. Study duration is 12 weeks. The aim is to assess at what timepoints specific MRI changes are seen with golimumab use; which aspects of rheumatoid involvement respond earliest; and if this precedes the timepoints when other clinical RA outcome measures change. Clinical response to treatment will involve assessing response to treatment on MRI of the participant’s most affected hand/wrist (as determined by Investigator assessment by examination at screening), as well as clinical outcome measures such as CRP, ESR and joint count assessments. In addition, participant reported outcomes (PROs) will be completed to assess the overall disease activity levels as reported by the participant. The PROs chosen include the conventional PROs EQ-5D, SF-36, FACIT-F and PtGA as these are well-established PROs that have demonstrated validity and reliability in assessing disease state, as well as a specific upper limb function PRO, the DASH. Visit timepoints are baseline, week 2, week 6 and week 12. At the end of the study, the participant will return to their normal treating rheumatologist for ongoing care.
Interventions
Participants on this trial will receive open-label golimumab 50mg subcutaneously every four weeks for a total of twelve weeks to assess the speed of golimumab response on MRI scans of the dominant hand/wrist and on other clinical outcome measures of rheumatoid arthritis. The participants will self-administer golimumab for the duration of the trial. There is no placebo or control arms. The participant will be asked about study drug compliance at each visit to ensure the participant is taking the
Participants on this trial will receive open-label golimumab 50mg subcutaneously every four weeks for a total of twelve weeks to assess the speed of golimumab response on MRI scans of the dominant hand/wrist and on other clinical outcome measures of rheumatoid arthritis. The participants will self-administer golimumab for the duration of the trial. There is no placebo or control arms. The participant will be asked about study drug compliance at each visit to ensure the participant is taking the study drug as prescribed.
Sponsors
Emeritus Research Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1 Male or female adult participants greater than or equal to 18years of age who can give informed consent, able to understand English and willing and able to complete the study activities. 2 Clinically defined active rheumatoid arthritis despite Methotrexate use (plus or minus other DMARDs), where active rheumatoid arthritis is defined as a DAS28-CRP equals 4.2 at screening. 3 Clinically active synovitis of the chosen hand or wrist on MRI at screening, as determined by the MRI reader. 4 The Methotrexate dose must be less than or equal to 25mg per week and the participant must also be on folic acid supplement according to local standard of care. The Methotrexate dose must have been stable for 3 months prior to baseline. 5 If the participant is on a DMARD in addition to Methotrexate at the time of screening (allowed but not required), the dose must have been stable for 3 months prior to baseline. 6 Non-steroidal anti-inflammatory drug (NSAID) medications are allowed but the participant is not required to be using these medications. If NSAIDs are being taken at the time of screening, the dose must have been stable for 10 days prior to baseline. 7 Prednisolone is allowed but the participant is not required to be using this medication. If prednisolone is being taken at the time of screening, the dose must be less than or equal to 10mg per day and the dose must have been stable for 2 weeks prior to baseline.
Exclusion criteria
1. Negative (i.e. no signs of active clinical synovitis) MRI of the chosen hand/wrist at screen as determined by the central MRI reader. 2. Inability to have MRI due to either claustrophobia or other contraindications to MRI. 3. Contraindication to use of golimumab (such as active tuberculises or other severe infections; opportunistic infections; concurrent use of golimumab with anakinra or abatacept; hypersensitivity to the active substance or any of the excipients; risk of Hepatitis B reactivation [i.e. surface antigen positive]; congestive heart failure; demyelinating disorders). 4. No pregnant or breastfeeding; willing to use contraception 5. Previous biologic use of any class. 6. Previous use of a JAK inhibitor. 7. Active Tuberculosis (TB) as determined by local Quanti-FERON gold and local chest x-ray. If latent TB is diagnosed, the participant may be enrolled into the study providing treatment for latent TB according to local standard of care is initiated prior to the first dose of golimumab. If results are available from a chest x-ray and/or QuantiFERON gold within the three months prior to baseline, there is no need to repeat and these results can be used to assess eligibility. 8. Recent infection requiring intravenous antibiotics in the previous three months. 9. Moderate to severe, uncontrolled, heart failure. 10. Positive Hepatitis B, Hepatitis C or HIV laboratory tests. If results are available from Hepatitis B, Hepatitis C or HIV laboratory tests within the three months prior to baseline, there is no need to repeat and these results can be used to assess eligibility. 11. Malignancy in the previous 5 years. Adequately treated Squamous cell carcinoma, basal cell carcinoma and carcinoma in situ of the cervix are acceptable. 12. History of demyelinating disorders, including multiple sclerosis. 13. Live vaccines in the previous three months or plans to receive a live vaccine while on study (inactivated vaccines are acceptable). 14. Latex allergy or if the participant has a latex allergy, no caregiver who is able to give the golimumab injections.
Outcome results
None listed