Inflammatory ArthritisPhase 2NCT06037811
Early Adalimumab Induction for Immune Checkpoint Inhibitor Associated Inflammatory Arthritis
A Phase 2 study testing Adalimumab and Prednisone in people with Inflammatory Arthritis and Immune-related Adverse Event, run by Tom Appleton at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Arthritis, Immune-related Adverse Event
- What is being tested?
- Adalimumab and Prednisone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 15 Apr 2024to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
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- 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 study (adalimumab group only)
- Written informed consent provided by patient or power of attorney
Who cannot join
- 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, undifferentiated inflammatory arthritis, undifferentiated connective tissue disease
- 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 fungal infection, opportunistic infection, hepatitis B/C, or HIV
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
St. Joseph's Health Care
London, Ontario, N6A 4V2
Maha El-shimy, 519-646-6000, maha.el-shimy@sjhc.london.on.ca
Dr. Tom Appleton, MD, FRCPC, PhD
About this study
Official title: Early Adalimumab Induction for Treatment of Steroid Dependent Immune Checkpoint Inhibitor Associated Inflammatory Arthritis: A Pragmatic Randomized Clinical Trial
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. It is hoped that adalimumab at the early stages of the ir-IA will reduce the symptoms and therefore reduce the need for steroids. This study is a pragmatic randomized clinical trial. Patients will be randomized 1:1 to each treatment group. To evaluate the steroid sparing effect of early induction six doses of Adalimumab will be administered to patients in the study treatment arm as compared to the usual standard of care of a predefined corticosteroid regimen and taper at 12 weeks administered in the control group.
- Being tested
- Adalimumab, Prednisone
- Keywords
- Immune Checkpoint Inhibitor, Adalimumab, TNF-alpha inhibitor
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Participants will be randomized 1:1 (non-blinded) to receive either adalimumab (40 mg subcutaneous every 2 weeks for 12 weeks) and prednisone vs prednisone alone. Addition of methotrexate (MTX) and/or hydroxychloroquine (HCQ) is permitted, as needed, at the discretion of the treating rheumatologist. No additional conventional synthetic, targeted synthetic or biologic DMARDs are permitted during the trial.
PrednisoneDrug
Also called Glucocorticoid, Corticosteroid
Prednisone as per standard of care.
The 12-week glucocorticoid regimen and taper will be standardized between the groups. At Baseline, all participants will be switched to oral prednisone dose at 10, 20, 30, 40, 50, or 60 mg once daily. The initial dose of prednisone is at the discretion of the investigator, based on disease severity and comorbid medical conditions, at a minimum of 10 mg once daily at Baseline. At Baseline, if a participant is on a dose other than 10, 20, 30, 40, 50, or 60 mg QD, the dose will be rounded up or down, as clinically indicated per investigator discretion, to the nearest of these doses. The prednisone taper regimen is tailored to each patient based on the starting dose over a 12-week period.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group | Active comparator | Baseline oral prednisone dose taken daily for one week, then weekly prednisone taper for 12 weeks or until stopped according to the 12-week Glucocorticoid Tapering Schedule Receives: Drug: Adalimumab; Drug: Prednisone |
| Adalimumab group | Active comparator | Adalimumab 40mg SC every 2 weeks x 6 doses + Baseline oral prednisone dose taken daily for one week, then weekly prednisone taper for 12 weeks or until stopped according to the 12-week Glucocorticoid Tapering Schedule. Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of participants on prednisone
Definition of success: Thirty percent fewer participants on prednisone in Group 2 vs Group 1.
Measured: at 12 weeks
Cumulative prednisone dose
Definition of success: Thirty percent reduction in the cumulative dose of steroids in Group 2 compared to Group 1.
Measured: at 12 weeks
Secondary outcomes (5)
percentage of participants on prednisone
Definition of success: Thirty percent difference between the two groups
Measured: 24 weeks
Cumulative prednisone dose
Definition of success: Thirty percent difference between the two groups
Measured: 24 weeks
percentage of dose reduction of prednisone
Definition of success: Thirty percent difference between the two groups
Measured: At 12 and 24 weeks
percentage of participants with immune-related inflammatory arthritis in remission (based on opinion of investigator)
Definition of success: Thirty percent difference between the two groups
Measured: at 12 and 24 weeks
percentage of participants with immune-related inflammatory arthritis resolution (based on opinion of investigator)
Definition of success: Thirty percent difference between the two groups
Measured: at 12 and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2023
- Study start15 Apr 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tom Appleton
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Research Group in Immuno-Oncology, Western University
- Responsible party
- Sponsor-investigator, Tom Appleton, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06037811
- Sponsor's protocol ID
- CanRIO ADA2023
- Status last verified
- Feb 2026
- First submitted
- 31 Aug 2023
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Adalimumab Induction for Treatment of Steroid Dependent Immune Checkpoint Inhibitor Associated Inflammatory Arthritis: A Pragmatic Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06037811
- Acronym / sponsor ID
- CanRIO ADA2023
- Keywords
- Immune Checkpoint Inhibitor, Adalimumab, TNF-alpha inhibitor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tom AppletonUniversity, hospital or other
- Collaborators
- Canadian Research Group in Immuno-Oncology, Western University
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. It is hoped that adalimumab at the early stages of the ir-IA will reduce the symptoms and therefore reduce the need for steroids. This study is a pragmatic randomized clinical trial. Patients will be randomized 1:1 to each treatment group. To evaluate the steroid sparing effect of early induction six doses of Adalimumab will be administered to patients in the study treatment arm as compared to the usual standard of care of a predefined corticosteroid regimen and taper at 12 weeks administered in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care group | Active comparator | Drug: Adalimumab, Drug: PrednisoneBaseline oral prednisone dose taken daily for one week, then weekly prednisone taper for 12 weeks or until stopped according to the 12-week Glucocorticoid Tapering Schedule |
| Adalimumab group | Active comparator | Drug: AdalimumabAdalimumab 40mg SC every 2 weeks x 6 doses + Baseline oral prednisone dose taken daily for one week, then weekly prednisone taper for 12 weeks or until stopped according to the 12-week Glucocorticoid Tapering Schedule. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- • Patients are deemed eligible for study participation if they meet all the following:
- 1 or more swollen joints OR
- 1 or more tenosynovitis OR
- 1 or more enthesitis
- Patients requiring prednisone at a dose of at least 10 mg daily (or equivalent) OR
Key exclusion criteria (14 listed)
- Patients are excluded if they meet any of the following:
- Previous diagnosis of inflammatory arthritis or other rheumatic disease (prior to current acute episode)
- Tenosynovitis, synovitis or enthesitis attributed to another cause, fracture or acute gout/CPPD flare.
- Presence of a contraindication to adalimumab therapy
- History of previous TNF inhibitor use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdalimumabParticipants will be randomized 1:1 (non-blinded) to receive either adalimumab (40 mg subcutaneous every 2 weeks for 12 weeks) and prednisone vs prednisone alone. Addition of methotrexate (MTX) and/or hydroxychloroquine (HCQ) is permitted, as needed, at the discretion of the treating rheumatologist. No additional conventional synthetic, targeted synthetic or biologic DMARDs are permitted during the trial. | Drug | Adalimumab group, Standard of care group |
| PrednisoneAlso: Glucocorticoid, CorticosteroidPrednisone as per standard of care. The 12-week glucocorticoid regimen and taper will be standardized between the groups. At Baseline, all participants will be switched to oral prednisone dose at 10, 20, 30, 40, 50, or 60 mg once daily. The initial dose of prednisone is at the discretion of the investigator, based on disease severity and comorbid medical conditions, at a minimum of 10 mg once daily at Baseline. At Baseline, if a participant is on a dose other than 10, 20, 30, 40, 50, or 60 mg QD, the dose will be rounded up or down, as clinically indicated per investigator discretion, to the nearest of these doses. The prednisone taper regimen is tailored to each patient based on the starting dose over a 12-week period. | Drug | Standard of care group |
Primary outcome
percentage of participants on prednisone
Time frame: at 12 weeks
Definition of success: Thirty percent fewer participants on prednisone in Group 2 vs Group 1.
Cumulative prednisone dose
Time frame: at 12 weeks
Definition of success: Thirty percent reduction in the cumulative dose of steroids in Group 2 compared to Group 1.
5 secondary outcomes
percentage of participants on prednisone
Time frame: 24 weeks
Cumulative prednisone dose
Time frame: 24 weeks
percentage of dose reduction of prednisone
Time frame: At 12 and 24 weeks
percentage of participants with immune-related inflammatory arthritis in remission (based on opinion of investigator)
Time frame: at 12 and 24 weeks
percentage of participants with immune-related inflammatory arthritis resolution (based on opinion of investigator)
Time frame: at 12 and 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adalimumab and Prednisone in people with Inflammatory Arthritis and Immune-related Adverse Event, run by Tom Appleton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tom Appleton, MD, PhD, FRCPC (519-646-6100, tom.appelton@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of participants on prednisone (time frame: at 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.