A phase 4, longitudinal, single-arm, open-label treatment study of subcutaneous golimumab effectiveness assessed by both speed of magnetic resonance imaging (MRI) changes in the hand/wrist and clinical response outcomes in patients with rheumatoid arthritis.
- Conditions
- Rheumatoid arthritisInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12620000827932
- Lead Sponsor
- Emeritus Research Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 18
1Male 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.
2Clinically 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.
3Clinically active synovitis of the chosen hand or wrist on MRI at screening, as determined by the MRI reader.
4The 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.
5If 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.
6Non-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.
7Prednisolone 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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method A descriptive summary of the MRI findings using RAMRIS score in the chosen hand/wrist from screening (screening MRI to serve as the baseline MRI) to the MRI findings using RAMRIS score in the chosen hand/wrist at weeks 2, 6 and 12 in participants with rheumatoid arthritis on a stable background of methotrexate who are given subcutaneous golimumab treatment.[Weeks 2, 6, 12]
- Secondary Outcome Measures
Name Time Method