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Enbrel with Sofusa DoseConnect for Rheumatoid Arthritis
Study Summary
This trial is testing a new way of giving Enbrel to people with RA. All patients will start with a low dose of Enbrel, and if it's well tolerated, the dose will be increased.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- I have at least 3 swollen and 3 tender joints.I have no cancer history in the last 5 years, except for treated skin cancer or localized cervical, colon, or bladder conditions.I have been taking more than 30 mg/day of opioids for most of the past week.I haven't taken leflunomide in the last 8 weeks, or 4 weeks if I had a cholestyramine washout.I have been diagnosed with rheumatoid arthritis.I have been diagnosed with rheumatoid arthritis.I have been on Enbrel therapy, taking it weekly for at least 12 weeks with no more than 1 missed dose.I was diagnosed with arthritis before I turned 17.I have been on a stable dose of specific arthritis medications for the required time.I haven't taken any biologic treatments other than Enbrel in the last 24 weeks.I've been on a stable dose of specific arthritis medications for the required time.I do not have active or untreated latent tuberculosis.I have not had joint surgery in the last 8 weeks.I have been diagnosed with or shown signs of a disease that affects the protective covering of my nerves.I have been on a stable dose of my RA medication for at least 2 weeks.I haven't taken MTX, hydroxychloroquine, or sulfasalazine in the last 4 weeks.I have symptoms of RA outside my joints, excluding nodules.I have or had hepatitis B or C, but if treated for hepatitis C, I am now cured.I am currently breastfeeding or stopped less than 12 weeks ago.I have a history of serious blood, kidney, or liver conditions.I agree to use birth control during and for 3 months after the study.I have been diagnosed with rheumatoid arthritis.I have been on Enbrel therapy for at least 12 weeks with no more than 1 missed dose.I've been on a stable dose of my rheumatoid arthritis medication for the required time.I have at least 3 swollen and 3 tender joints.I haven't used any corticosteroid injections in the last 4 weeks.I haven't had hyaluronic acid injections in my joints in the last 3 months.I agree to use birth control during and for 3 months after the study.My condition meets the specific disease criteria required.I have been on a stable dose of my RA medication for at least 2 weeks.I have taken more than 10 mg/day of steroids in the last 4 weeks.I don't have inflammatory or autoimmune diseases that could affect RA assessments, except for Sjogren's syndrome or fibromyalgia.I have been treated with more than two types of specific arthritis medications.My rheumatoid arthritis is severely disabling.I have not received any blood products in the last 12 weeks.I haven't had any live vaccines in the last 8 weeks and don't need any during the study.I have been on Enbrel therapy for at least 12 weeks with no more than 1 missed dose.I haven't taken any non-biologic DMARDs in the last 4 weeks.I do not have serious heart issues, uncontrolled diabetes, recent major heart or brain events.My condition meets specific disease criteria.I have used chlorambucil or cyclophosphamide in the last 24 weeks.I have had infections like histoplasmosis or listeriosis.I haven't had frequent infections or been hospitalized for an infection in the last month.
- Group 1: Sofusa Enbrel
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
Is participation in this research permissible for minors?
"Within the scope of this medical trial, enrollees must be over 18 years old and under 80."
Has the FDA ratified Sofusa DoseConnect for medicinal use?
"As this clinical trial is in Phase 1, meaning there is a scarcity of safety and efficacy data, our team at Power assigned Sofusa DoseConnect the lowest possible score on the scale: one."
What conditions can Sofusa DoseConnect be used to treat?
"Sofusa DoseConnect is an appropriate treatment for moderate to severe conditions, such as disease, rheumatoid arthritis and ankylosing spondylitis."
Could you elaborate on the research that has been conducted concerning Sofusa DoseConnect?
"Currently, there are 34 ongoing investigations into Sofusa DoseConnect with 10 trials in their final phase. Of those 662 trial sites across the world, several of them can be found in Xi'an, Shaanxi."
What is the participant capacity of this experimental trial?
"Affirmative. Clinicaltrials.gov shows that this clinical trial is open for enrollment and was first published on October 1st 2022, with a recent update of September 7th 2022. A total of 10 volunteers will be needed from one location to complete the study."
Do I fulfill the requirements to enroll in this medical experiment?
"This clinical trial is recruiting 10 individuals with rheumatoid arthritis aged between 18 and 80. To be eligible, applicants must meet the following criteria: they should have been taking oral or subcutaneous methotrexate (up to 25 mg/week) or other authorised conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs), such as leflunomide, hydroxychloroquine, sulfasalazine for at least 12 weeks before enrolling in the study; if on methotrexate treatment, a stable dose of folic acid supplements must have been taken over the same period prior to"
Do you still have availability for participation in this experiment?
"According to the clinicaltrials.gov portal, this trial is actively looking for participants and began accepting applications on October 1st 2022. The study was last updated 7th September of that same year."
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