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Folic Acid, Anhydrous

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.

Table of Contents

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.[1]

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.[1]

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.[1]

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.[1]

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:

  1. Identifying pre-treatment profiles that can predict response to tofacitinib treatment in PsA patients.
  2. Comparing the clinical efficacy of tofacitinib, methotrexate, and etanercept in different groups of PsA patients.
  3. Determining the molecular mechanisms that predict and underlie clinical response to these medications.[1]

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).[1]

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.[1]

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.

Aspect Details
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

FAQ

  • What is the main purpose of the TOFA-PREDICT clinical trial? The main purpose of the TOFA-PREDICT clinical trial is to identify pre-treatment profiles that can predict how well patients with psoriatic arthritis will respond to treatment with tofacitinib. The study uses various data types, including clinical, genetic, and imaging information.
  • How is Folic Acid, Anhydrous used in this clinical trial? Folic Acid, Anhydrous is used as a supplementary medication in this trial. It is often prescribed alongside methotrexate to help reduce some of the side effects associated with methotrexate treatment in psoriatic arthritis patients.
  • Who can participate in this clinical trial? Participants must be between 18-75 years old, diagnosed with psoriatic arthritis according to CASPAR criteria, have active arthritis with at least 2 swollen and 2 tender joints, and meet specific criteria depending on their previous treatment history. Some patients should be new to certain treatments, while others should have experience with specific medications.
  • What are the main outcomes the researchers are looking at in this trial? The main outcomes include achieving Minimal Disease Activity (MDA) at week 16 and identifying baseline molecular network profiles that predict treatment response. They're also looking at changes in disease activity scores, individual clinical parameters, and molecular networks before and after treatment.
  • How long does the treatment in this trial last? The treatment period in this trial lasts for 16 weeks. During this time, patients will receive their assigned treatment and undergo various assessments to measure their response to the medication.

Ongoing Clinical Trials on Folic Acid, Anhydrous

  • Study to Predict Tofacitinib Effectiveness in Psoriatic Arthritis Patients Using Tofacitinib, Methotrexate, and Folic Acid

    Not recruiting

    1 1 1 1
    Investigated drugs:
    The Netherlands

Glossary

  • Psoriatic Arthritis (PsA): A type of inflammatory arthritis that affects some people with psoriasis. It causes joint pain, stiffness, and swelling.
  • CASPAR criteria: Classification Criteria for Psoriatic Arthritis, a standardized set of criteria used to diagnose psoriatic arthritis.
  • DMARD: Disease-Modifying Antirheumatic Drug, a category of drugs used to treat inflammatory arthritis by targeting the underlying disease process.
  • csDMARD: Conventional synthetic Disease-Modifying Antirheumatic Drug, such as methotrexate or sulfasalazine.
  • bDMARD: Biologic Disease-Modifying Antirheumatic Drug, such as etanercept or adalimumab.
  • tsDMARD: Targeted synthetic Disease-Modifying Antirheumatic Drug, such as tofacitinib.
  • Tofacitinib: A medication used to treat psoriatic arthritis by inhibiting certain enzymes involved in inflammation.
  • Methotrexate: A medication commonly used to treat psoriatic arthritis and other autoimmune conditions.
  • Folic Acid, Anhydrous: A form of vitamin B9 often given with methotrexate to reduce side effects.
  • Minimal Disease Activity (MDA): A state of low disease activity in psoriatic arthritis, used as a treatment target.
  • ACR response: American College of Rheumatology response criteria, a measure of improvement in arthritis symptoms.
  • DAS28: Disease Activity Score 28, a measure of disease activity in arthritis using 28 specific joints.
  • PASI score: Psoriasis Area and Severity Index, a tool used to measure the severity of psoriasis.

References

  1. http://clinicaltrials.eu/trial/study-to-predict-tofacitinib-effectiveness-in-psoriatic-arthritis-patients-using-tofacitinib-methotrexate-and-folic-acid/