In short
This article discusses the use of Folic Acid, Anhydrous in clinical trials, particularly in the context of psoriatic arthritis treatment. The focus is on a study called TOFA-PREDICT, which aims to predict the effectiveness of various treatments, including tofacitinib, methotrexate, and folic acid, in patients with psoriatic arthritis. The trial seeks to identify factors that can help determine which patients will respond best to these treatments.
At a glance
- Study Name
- TOFA-PREDICT
- Main Objective
- Predict response to tofacitinib in psoriatic arthritis patients
- Treatments Studied
- Tofacitinib, Methotrexate, Etanercept, Folic Acid
- Patient Groups
- DMARD-naïve and DMARD non-responsive PsA patients
- Primary Endpoints
- Minimal Disease Activity at week 16, Baseline molecular network profile
- Secondary Endpoints
- Changes in molecular network, disease activity scores, and individual clinical parameters
- Treatment Duration
- 16 weeks
- Folic Acid Usage
- Supplementary medication, max daily dose 1.5 mg, max total dose 160 mg
What is Folic Acid?
Folic acid, also known as folate, is a B vitamin that plays a crucial role in various bodily functions. In the context of this study, we're focusing on folic acid in its anhydrous form, which means it doesn't contain water molecules. The medication used in the trial is called "Foliumzuur Aurobindo 5 mg, tabletten," which is a tablet form of folic acid.
Role in Psoriatic Arthritis Treatment
Folic acid is being studied in combination with other medications for the treatment of psoriatic arthritis (PsA). PsA is a type of inflammatory arthritis that affects some people with psoriasis, causing joint pain, stiffness, and swelling.
In this clinical trial, folic acid is used alongside other medications, particularly methotrexate. Methotrexate is a common treatment for PsA, but it can deplete folate levels in the body. Folic acid supplementation is often prescribed to help reduce some of the side effects associated with methotrexate use.
Dosage and Administration
According to the trial information, the folic acid used in this study has the following characteristics:
- It comes in a tablet form of 5 mg strength.
- The maximum daily dose is 1.5 mg.
- The maximum total dose amount is 160 mg over the course of the study.
- It is administered orally (taken by mouth).
- The maximum treatment period is 16 weeks.
Clinical Trial Information
The clinical trial involving folic acid is part of a larger study called "TOFA-PREDICT". This study aims to predict the effectiveness of a medication called tofacitinib in treating psoriatic arthritis. The main objectives of the study include:
- Identifying pre-treatment profiles that can predict response to tofacitinib treatment in PsA patients.
- Comparing the clinical efficacy of tofacitinib, methotrexate, and etanercept in different groups of PsA patients.
- Determining the molecular mechanisms that predict and underlie clinical response to these medications.
Eligibility Criteria for the Study
To participate in this study, patients must meet certain criteria. Some key inclusion criteria are:
- Age between 18-75 years old
- Diagnosed with psoriatic arthritis according to CASPAR criteria
- Disease duration of at least 8 weeks
- Evidence of active arthritis (at least 2 swollen joints and 2 tender joints)
There are also specific criteria for different groups in the study, such as those who have not used certain medications before (DMARD-naïve) and those who have not responded well to previous treatments (DMARD non-responsive).
Potential Benefits and Outcomes
The study aims to measure several outcomes that could benefit patients with psoriatic arthritis:
- Minimal Disease Activity (MDA): This is a measure of how well the disease is controlled. The study will assess if patients achieve MDA at week 16 of treatment.
- Changes in disease activity scores: The researchers will look at various measures of disease activity, including joint counts, skin symptoms (PASI score), and quality of life measures.
- Molecular changes: The study will examine how the treatments affect various biological markers in the body, which could help predict which patients will respond best to different treatments.
By participating in this study, patients may contribute to advancing our understanding of psoriatic arthritis treatment and potentially benefit from closely monitored care and innovative treatment approaches.