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Methotrexate for Rheumatoid Arthritis
Study Summary
This trial is testing a new drug, ATI-450, to see if it is better than placebo at treating RA when used with methotrexate.
- Rheumatoid Arthritis
Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2015 Phase 3 trial • 139 Patients • NCT02001987Trial Design
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- You have a current condition that causes inflammation and can affect the evaluation of your RA, except for RA itself.You have already tried two or more biologic medications, or one or more JAK inhibitors, or a combination of one biologic medication and one JAK inhibitor.You have been taking methotrexate (MTX) for at least 12 weeks and have not changed the dosage during that time.You have a medical condition that is not related to inflammation and is not under control. This condition may put you at risk during the study or may affect the interpretation of the study results. Examples of such conditions include history of cancer, recurring infections, and blood clots.
- Group 1: ATI-450 20mg BID plus Methotrexate
- Group 2: ATI-450 50mg BID plus Methotrexate
- Group 3: Placebo plus Methotrexate
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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
Are there any dangerous side effects associated with Methotrexate?
"There is some data supporting Methotrexate's safety, but none indicating its efficacy. Consequently, it received a score of 2."
How many study participants are being enrolled in this clinical trial?
"That is accurate, the clinical trial is ongoing and recruiting patients. The original posting was on February 2nd, 2022 with the most recent update occurring on August 23rd, 2022. There are 9 different recruitment sites for this study and the goal is to have 240 total participants."
Does this research include elderly participants?
"In order to be eligible for this study, patients must between 18 and 75 years old. There are 53 other trials available for minors and 347for senior citizens."
In how many different medical clinics is this clinical study being conducted today?
"Currently, this trial is taking place in 9 clinics which are situated in Mesquite, La Jolla, Duncansville and 6 other cities. If you're interested in participating, please consult the list of locations to find the one nearest you to reduce travel costs and time."
Are there any available positions for patients in this trial?
"Yes, the clinical trial is currently open and recruiting patients. According to the most recent update on 8/23/2022, they are looking for 240 participants total at 9 different locations."
How can I get involved with this research?
"This clinical trial is open to adults with rheumatoid arthritis aged 18-75. Eligible patients must be able to understand and sign the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved patient informed consent form prior to any study procedures, have a diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria, have active moderate to severe RA at screening, and be stable on methotrexate therapy for at least 12 weeks."
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