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PET Radioligands for Rheumatoid Arthritis

Phase 1
Recruiting
Led By Robert B Innis, M.D.
Research Sponsored by National Institute of Mental Health (NIMH)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
IIM patients with age greater than or equal to 18, willing and able to complete all study procedures, able to give written informed consent, and meeting specific diagnostic criteria. If female, no plans for pregnancy within the ensuing 3 months.
Be older than 18 years old
Must not have
All participants should not have taken NSAIDs or willow bark tea for two weeks prior to the PET scan.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying two drugs as imaging agents to see if they can help detect inflammation.

Who is the study for?
Adults over 18 with rheumatoid arthritis or idiopathic inflammatory myopathy (IIM), and healthy adults enrolled in specific protocols, can join this trial. Participants must be able to perform all study procedures and provide consent. Women should not plan to become pregnant soon. NSAIDs use is a disqualifier, along with certain medical conditions.
What is being tested?
The trial tests if two new drugs, [11C]ER176 and [11C]MC1, improve PET scan imaging of inflammation in patients with arthritis or IIM compared to healthy volunteers. It involves taking celecoxib orally, undergoing PET scans, and possibly CT scans or MRIs.
What are the potential side effects?
Potential side effects may include reactions from the injected radioligands used for PET scanning or side effects from celecoxib such as stomach pain, swelling due to fluid retention, dizziness, headache or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18, can follow the study plan, agree to participate, and if female, not planning to get pregnant soon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I haven't taken NSAIDs or willow bark tea for two weeks before a PET scan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Uptake of the radioligands in the affected body area

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single armExperimental Treatment2 Interventions
all groups get the same studies
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Celecoxib
2019
Completed Phase 4
~1740

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Mental Health (NIMH)Lead Sponsor
2,918 Previous Clinical Trials
2,740,027 Total Patients Enrolled
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,262 Total Patients Enrolled

Media Library

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