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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 hours
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Uptake of the radioligands in the affected body area

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
2,785 Previous Clinical Trials
2,689,645 Total Patients Enrolled
14 Trials studying Inflammation
1,266 Patients Enrolled for Inflammation
Robert B Innis, M.D.Principal InvestigatorNational Institute of Mental Health (NIMH)
27 Previous Clinical Trials
1,193 Total Patients Enrolled
1 Trials studying Inflammation
61 Patients Enrolled for Inflammation

Media Library

Single arm Clinical Trial Eligibility Overview. Trial Name: NCT03912428 — Phase 1
Inflammation Research Study Groups: Single arm
Inflammation Clinical Trial 2023: Single arm Highlights & Side Effects. Trial Name: NCT03912428 — Phase 1
Single arm 2023 Treatment Timeline for Medical Study. Trial Name: NCT03912428 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the research team actively looking for participants to join this experiment?

"As of now, clinicaltrials.gov suggests that this medical study is still seeking participants since its inception in June 14th 2019 and last update on October 14th 2022."

Answered by AI

Who is the ideal demographic for enrolling in this research project?

"This clinical trial seeks 96 participants with myositis, aged between 18 and 99. The essential prerequisites are as follows: 1) Healthy subjects must be of or above the age of consent, willing to comply with all study protocols, medically sound, enrolled in either protocol #01M0254 "The Evaluation of Participants with Mood and Anxiety Disorders and Healthy Volunteers" or # 17-M-0181 "Recruitment and Characterization of Healthy Research Volunteers for NIMH Intramural Studies", age-, sex-, genotype-matched candidates if applicable (Phase 2), females who have no plans to become pregnant within 3"

Answered by AI

Has this treatment been given a green light by the FDA?

"There is limited data on safety and efficacy, so this intervention was estimated to have a score of 1."

Answered by AI

How many participants are permitted to take part in this clinical experiment?

"Affirmative. The clinicaltrials.gov website indicates that this investigation is actively recruiting participants, with the first post dating back to June 14th 2019 and a recent edit on October 14th 2022. 96 individuals are sought after at 1 centre of research."

Answered by AI

In what instances is this remedy typically prescribed?

"This medication has typically been employed to reduce pain, but it is also helpful for managing other maladies such as primary dysmenorrhoea, rheumatoid arthritis, and ankylosing spondylitis."

Answered by AI

Does the minimum qualifying age for this research exceed twenty-five years old?

"This trial is looking for patients that are between 18 and 99 years of age. For minors, there are 111 clinical trials available, whereas those over 65 have access to 748 different studies."

Answered by AI
Recent research and studies
~55 spots leftby Feb 2029