BridgeMD
New treatment option for Inflammatory Arthritis
Official title Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
ClinicalTrials.gov ID: NCT06037811
What this study is testing
What is Adalimumab?
Adalimumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for inflammatory arthritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will examine the effectiveness of administering adalimumab as a treatment for patients in the early stages of steroid-dependent immune checkpoint Inhibitor associated inflammatory arthritis (ir-IA). Adalimumab (ADA) is a TNF inhibitor (TNFi) that is well established as a standard of care treatment for numerous types of inflammatory arthritis.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients are deemed eligible for study participation if they meet all the following:
- Adult patients (age 18 or older)
- New (within the last 6 months prior to enrollment) inflammatory arthritis defined by any of the following at the time of screening (either on...
- 1 or more swollen joints OR
- 1 or more tenosynovitis OR
You likely can't join if
- Patients are excluded if they meet any of the following:
- Previous diagnosis of inflammatory arthritis or other rheumatic disease (prior to current acute episode)
- Including but not limited to: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, psoriatic arthritis...
- Tenosynovitis, synovitis or enthesitis attributed to another cause, fracture or acute gout/CPPD flare.
- Presence of a contraindication to adalimumab therapy
- Any of the following in the 7 days prior to initiation of adalimumab: positive tuberculin skin test (\>5mm induration within 48 to 72 hours) or...
See the full eligibility criteria
- Patients are deemed eligible for study participation if they meet all the following:
- Adult patients (age 18 or older)
- New (within the last 6 months prior to enrollment) inflammatory arthritis defined by any of the following at the time of screening (either on physical exam or by ultrasound) by a certified rheumatologist:
- 1 or more swollen joints OR
- 1 or more tenosynovitis OR
- 1 or more enthesitis
- Arthritis onset with taking ICI therapy OR within 4 weeks of stopping ICI therapy including CTLA-4, PD-1, and PDL-1 inhibitors
- Initiation of ICI therapy must predate the onset of inflammatory arthritis
- Glucocorticoid dependence at any time before enrolment, defined by either:
- Patients requiring prednisone at a dose of at least 10 mg daily (or equivalent) OR
- Patients for whom at least 1 glucocorticoid taper failed to control the disease activity
- Negative tuberculosis (TB) status within the past 12 months (TB skin test or quantiferon) for the patients in the adalimumab group. If not available, the status should be confirmed within 6 months of enrollment in the...
- Written informed consent provided by patient or power of attorney
- Patients are excluded if they meet any of the following:
- Previous diagnosis of inflammatory arthritis or other rheumatic disease (prior to current acute episode)
- Including but not limited to: rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, Sjogren's syndrome, psoriatic arthritis, reactive arthritis, ankylosing spondylitis, systemic vasculitis...
- Tenosynovitis, synovitis or enthesitis attributed to another cause, fracture or acute gout/CPPD flare.
- Presence of a contraindication to adalimumab therapy
- Any of the following in the 7 days prior to initiation of adalimumab: positive tuberculin skin test (\>5mm induration within 48 to 72 hours) or positive quantiferon, evidence of untreated active infection including...
- Personal history of congestive heart failure
- Personal or family history of demyelinating neurologic disease
- History of previous TNF inhibitor use
- Current use of other disease modifying agents including: Chloroquine, Sulfasalazine, Azathioprine, 6-MP, and Leflunomide
- Presence of a concomitant non-rheumatic irAE which required systemic immunosuppression within the past 3 months e.g. pneumonitis, hepatitis, colitis, scleritis, nephritis
- Require chronic steroid treatment for adrenal insufficiency or another medical reason other than ir-IA
- Pregnancy, breastfeeding or childbearing potential without practicing highly effective contraception.
- Inability to participate in follow-up visits
The study team makes the final eligibility decision.
Where it's taking place
- London, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include London, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.