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TNF Inhibitor

Adalimumab for Arthritis

Phase 2

Recruiting

Research Sponsored by Tom Appleton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

New (within the last 6 months prior to enrollment) inflammatory arthritis defined by swollen joints, tenosynovitis, or enthesitis

Arthritis either does not respond completely to prednisone doses of 10mg (equivalent) OR recurs with prednisone taper below 10mg daily

Must not have

Previous diagnosis of inflammatory arthritis or other rheumatic disease (prior to current acute episode)

Personal history of congestive heart failure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12 and 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

"This trial will test if giving adalimumab to patients with early steroid-dependent immune checkpoint Inhibitor associated inflammatory arthritis can reduce symptoms and decrease the need for steroids. Adalimumab is a

Who is the study for?

This trial is for adults over 18 with arthritis that started during or within 4 weeks after immune checkpoint inhibitor therapy, and doesn't fully improve with low-dose steroids. Participants must have swollen joints or related inflammation, no recent tuberculosis, and must have given consent.

What is being tested?

The study tests if early treatment with Adalimumab can reduce symptoms of inflammatory arthritis caused by cancer immunotherapy better than the usual steroid regimen. Patients are randomly assigned to receive either Adalimumab or Prednisone.

What are the potential side effects?

Adalimumab may cause injection site reactions, infections due to lowered immunity, headaches, rash, and gastrointestinal issues. Prednisone use can lead to increased appetite, mood changes, high blood pressure, bone weakening among other side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had swelling in my joints or tendons diagnosed as new arthritis in the last 6 months.

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My arthritis doesn't fully improve with low-dose prednisone or comes back when the dose is reduced.

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I developed arthritis after starting or within 4 weeks of stopping immunotherapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with inflammatory arthritis or another rheumatic disease before this current episode.

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I have a history of heart failure.

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I have inflammation in my tendons, joints, or attachment points not caused by another condition, a fracture, or a gout/CPPD flare-up.

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I cannot take adalimumab due to health reasons.

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I or my family have a history of diseases that affect the protective covering of nerves.

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I have used TNF inhibitors in the past.

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I am currently taking medication for another condition.

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I have had a non-joint related immune reaction needing treatment in the last 3 months.

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I have not had a positive TB test or any untreated infections like hepatitis or HIV recently.

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I am not pregnant, breastfeeding, and if capable of childbearing, I use effective contraception.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at weeks 12 and 24

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at weeks 12 and 24

This trial's timeline: 3 weeks for screening, Varies for treatment, and at weeks 12 and 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Cumulative prednisone dose

percentage of dose reduction of prednisone

percentage of participants on prednisone

+2 more

Other study objectives

Cancer status vs baseline: overall survival (OS), progression free survival (PFS)

EQ-5D (EuroQol 5 Dimension for evaluation of generic quality of life)

FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue Score)

+8 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Standard of care groupActive Control1 Intervention

Prednisone 10 mg daily for 2 weeks, then taper by 2.5 mg every 2 weeks until stopped.

Group II: Adalimumab groupActive Control2 Interventions

Adalimumab 40 mg subcutaneous every 2 weeks for 6 doses (12 weeks) + Prednisone 10 mg daily for 2 weeks, tapering by 2.5 mg every 2 weeks until stopped.

0 / 13Eligibility criteria met