A phase 4, single-arm, open-label treatment, descriptive study of upadacitinib effectiveness assessed by magnetic resonance imaging (MRI) changes in the hand/wrist and clinical response outcomes in participants with rheumatoid arthritis on methotrexate and who are biologic naïve.
- Conditions
- rheumatoid arthritisInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12622000032752
- Lead Sponsor
- Emeritus Research Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 7
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 and has been assessed by a Rheumatologist as suitable to commence upadacitinib as part of their rheumatoid arthritis management and will commence this treatment at baseline.
2Clinically defined active rheumatoid arthritis despite methotrexate use (with or without other DMARDs), where active rheumatoid arthritis is defined as a DAS28-CRP greater than or equal to 3.2 at screening.
3Clinically active synovitis (defined by synovitis sum score of greater than or equal to 3) 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 greater than or equal to 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 greater than or equal to 3 months prior to baseline and remain stable throughout the duration of the trial.
Note: the combination of leflunomide and methotrexate is allowed but with a cap of no more than 2 trial participants using this combination.
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 greater than or equal to 10 days prior to baseline and remain stable throughout the duration of the trial.
7Prednisolone or equivalent is allowed but the participant is not required to be using this medication. If prednisolone (or equivalent) is being taken at the time of screening, the prednisolone dose must be less than or equal to10mg per day (or equivalent) and the dose must have been stable for greater than or equal to 2 weeks prior to baseline and remain stable throughout the duration of the trial.
1.Negative MRI of the chosen hand/wrist (i.e. no signs of active clinical synovitis defined as synovitis sum wrist and MCP score less than 3) at screening as determined by the central MRI reader.
2.Inability to have MRI with gadolinium due to either claustrophobia or other contraindications to MRI with gadolinium.
3.Screening eGFR less than 60 mL/min/1.73m2
4.Any prior use of biologic treatment or targeted synthetic DMARD (JAK inhibitor).
5.Use of any intra-articular corticosteroid use in the previous 3 months in the chosen hand/wrist.
6.Any prior joint surgery in the chosen hand/wrist.
7.If the participant is a female of child-bearing potential: Currently pregnant or breastfeeding or plan to become pregnant or breastfeed during the course of the study. The participant must use contraception throughout treatment and for four weeks after the last dose.
Females who are not of child-bearing potential (post-menopausal women, permanently sterile) are not required to use contraception.
Same sex relationships are not required to use contraception.
8.Recent infection requiring intravenous antibiotics in the previous three months.
9.Any history of malignancy in the participant’s lifetime. Adequately treated squamous cell carcinoma, basal cell carcinoma and carcinoma in situ of the cervix are acceptable.
10.Live vaccines in the previous three months or plans to receive a live vaccine while on study (inactivated vaccines are acceptable).
11.Contraindication to use of upadacitinib.
12.Active Tuberculosis (TB) as determined by local QuantiFERON 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 upadacitinib. 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.
13.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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method