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RPH-104 for Recurrent Pericarditis
Phase 2 & 3
Waitlist Available
Research Sponsored by R-Pharm Overseas, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Presents with at least the third episode of pericarditis during screening and within ≤ 7 days prior to and including RI baseline
Recurrent pericarditis diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 24 (of the rw period)
Awards & highlights
Study Summary
This trial will assess the efficacy and safety of RPH-104 in patients with recurrent pericarditis. Pharmacokinetic and pharmacodynamic parameters will also be assessed.
Who is the study for?
This trial is for individuals with recurrent pericarditis, who've had at least one flare-up meeting specific criteria and are currently experiencing or have recently experienced another episode. Participants must be willing to stop taking certain anti-inflammatory drugs by Week 12 and follow contraceptive guidelines if applicable. People with severe allergies to RPH-104, certain health conditions, uncontrolled diabetes, organ transplants, recent malignancies, mental disorders affecting study compliance, substance abuse issues, severe kidney problems or those on other clinical trials are excluded.Check my eligibility
What is being tested?
The trial tests the effectiveness and safety of a medication called RPH-104 in patients with recurrent pericarditis compared to a placebo. It also looks into how the body processes multiple doses of RPH-104. Patients will be randomly assigned to receive either RPH-104 or a placebo while their response to treatment is monitored.See study design
What are the potential side effects?
While not specified here, potential side effects may include reactions related to hypersensitivity such as rash or itching (since people with known hypersensitivity are excluded), as well as any common drug-related adverse events like nausea, headache or fatigue.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had at least three episodes of pericarditis recently.
Select...
I have been diagnosed with recurrent pericarditis.
Select...
I agree to use effective birth control during the study.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 24 (of the rw period)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 24 (of the rw period)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time (days) to the pericarditis recurrence within 24 weeks after randomization in patients with recurrent pericarditis treated with RPH-104 compared to placebo.
Secondary outcome measures
Percentage of days with no or minimal pain in the first 16 weeks of the RW period in RPH-104 group compared to placebo.
Proportion of subjects who maintained Clinical Response at Week 16 of the RW period in RPH-104 group compared to placebo.
Side effects data
From 2017 Phase 1 trial • 35 Patients • NCT0266763952%
Nervous system disorders
32%
Gastrointestinal disorders
24%
Infections and infestations
12%
General disorders and administration site conditions
8%
Musculoskeletal and connective tissue disorders
8%
Pollakiuria
8%
Skin and subcutaneous tissue disorders
8%
Investigations
4%
Respiratory, thoracic and mediastinal disorders
4%
Psychiatric disorders
4%
Ear and labyrinth disorders
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment
Placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RPH-104 80 mgExperimental Treatment1 Intervention
Patients will receive RPH-104 dose 160 mg subcutaneously on Day 0, and 80 mg on Day 7, Day 14 and thereafter once in two weeks.
Group II: PlaceboPlacebo Group1 Intervention
Patients (who achieved clinical response defined above by the randomized withdrawal baseline) will receive placebo subcutaneously once every 2 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RPH-104
2016
Completed Phase 3
~60
Find a Location
Who is running the clinical trial?
Data Management 365Industry Sponsor
10 Previous Clinical Trials
4,074 Total Patients Enrolled
2 Trials studying Pericarditis
37 Patients Enrolled for Pericarditis
Keystat, LLCUNKNOWN
1 Previous Clinical Trials
102 Total Patients Enrolled
R-Pharm Overseas, Inc.Lead Sponsor
2 Previous Clinical Trials
116 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My diabetes is not well-controlled.I have had at least three episodes of pericarditis recently.I am willing to stop taking NSAIDs, colchicine, or corticosteroids by Week 12.I have been taking NSAIDs, colchicine, or corticosteroids at the same dose for at least 3 days.I am currently taking more than 60 mg/day of prednisone or its equivalent.My heart inflammation is due to a specific condition.I have severe kidney problems.I have not had any other cancers in the last 5 years.I have been diagnosed with recurrent pericarditis.I have had an organ transplant or might need one soon.You have mental health conditions that might make it hard for you to take part in the study.I have never had active tuberculosis or been at risk for it.I have had at least one episode of pericarditis.I can and will attend all required study visits and follow the study rules.Certain abnormal test results at the screening.I am not participating in other clinical trials or using unapproved medicines.You have a history of drinking too much alcohol or using drugs.I agree to use effective birth control during the study.I haven't taken certain medications recently.You have had serious allergic reactions to certain medications in the past.You are allergic to the study drug RPH-104 or any of its ingredients.I have not received a live vaccine in the last 3 months.My immune system is not working properly.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: RPH-104 80 mg
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being accepted to participate in this experiment?
"Unfortunately, this particular trial is not recruiting patients at the moment. The original posting was on September 1st, 2022 but the listing was updated on June 2nd, 2022. However, there are 1081 other trials that have active recruitment drives going on right now."
Answered by AI
How many people are taking part in this experiment at most?
"This particular trial is not taking new patients at the moment, with the last update to the study's status on clinicaltrials.gov being on June 2nd, 2022. However, if you are seeking other trials, there are 1078 for relapse and 3 for RPH-104 currently enrolling participants."
Answered by AI
What is the novelty of this research?
"There are 3 ongoing trials for RPH-104 taking place in 1 city and 4 countries. The first study was performed in 2021 by Data Management 365. That initial study completed its Phase 2 drug approval stage with 60 patients. To date, a total of 18290 studies have been conducted since the year 2021."
Answered by AI
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