Brooksville · Next to Oak Hill Hospital
Crohn's Disease Research Study
Still having symptoms after other treatments? See if you qualify for our study of an FDA‑approved medication.
- FDA‑approved medication
- No placebo
- No insurance needed
- 1
A Short Screening Call
Answer 3 quick questions here. Our team calls to go over your Crohn's and the treatments you've tried.
About a minute No commitment
- 2
Optional: Join the Study
If you qualify and want to: everyone receives Entyvio (vedolizumab), an FDA‑approved Crohn's medication, with no placebo. No insurance needed, free Uber rides to every visit, and you may receive up to $525 for your time.
Who is this study for?
You may be a fit if all of these sound like you:
- An adult, 18 to 80, diagnosed with Crohn's disease
- Still having moderate to severe symptoms, like belly pain or frequent diarrhea
- Tried steroids, an immune-suppressing medicine or a biologic, and it didn't work well enough or caused side effects
- Never treated with Entyvio (vedolizumab)
Patient Reviews
What people say
- Beth B.Rated 5 out of 5.
“Wonderful people and great communication! I highly recommend them!”
- Sharon C.Rated 5 out of 5.
“I was treated very well. Very Professional and very thorough. I highly recommend them...”
- Peter B.Rated 5 out of 5.
“They treat you like you matter”
Google Maps reviews of Access Research Institute.
Your Study Doctor
Meet Dr. Muddassir
Dr. Salman Muddassir, MD, FACP, is an internal medicine physician who leads this study right here in Brooksville and oversees your care at every visit.
He trains the doctors at Oak Hill Hospital
As Program Director of the Internal Medicine Residency at Oak Hill Hospital, right next door to our clinic, he teaches the next generation of physicians.
Voted Best Teaching Physician 6 times
During 13 years at the Seton Hall University Internal Medicine Program in New Jersey, where he also trained and served as Chief Resident.
Fellow of the American College of Physicians
The FACP after his name means his peers recognized his contributions to internal medicine. He also serves on Oak Hill Hospital's Quality Improvement & Safety Committee.
Outside the clinic, he's a husband and a father of three sons who loves hiking, traveling and adventure sports.
Check My EligibilityStudy Benefits
Study Benefits
What taking part in this Crohn's disease research study includes.
An FDA‑Approved Medication
Everyone in the study receives Entyvio (vedolizumab), approved for moderate to severe Crohn's disease. There is no placebo.
No Cost to You
The study medication, visits and tests, with no insurance needed, plus free Uber rides to every visit.
Compensation For Your Time
If you qualify and join the study, you may receive up to $525 in total for your time and travel to study visits.
Care From Our Research Doctors
Dr. Muddassir and our team see you at every visit.
How It Works
How It Works
Start with a short call. Joining the study is a separate choice.
Step 1: Answer 3 quick questions
It takes about a minute, right here.
Step 2: We call you
A short call about your Crohn's and the treatments you've tried, to see whether the study makes sense for you.
Step 3: Screening visit
At our Brooksville clinic, next to Oak Hill Hospital, we walk you through the consent form: what happens, the visit schedule, the risks, and your right to leave at any time. Screening includes lab work and a colonoscopy.
Step 4: Start the study
If you qualify and decide to join, your first doses of Entyvio are IV infusions at the clinic. After that you switch to a prefilled pen you use at home every 2 weeks, and our team shows you how.
Questions
Frequently Asked Questions
Find answers to common questions about our clinical research study.
What is this study?
It's a Phase 4 research study. Phase 4 studies look at a medication that is already FDA-approved. This one follows how people with moderate to severe Crohn's disease do on Entyvio (vedolizumab) when it's given at community clinics like ours, rather than at large academic hospitals. It tracks symptoms, lab results and quality of life over about a year.
What is the study medication?
Entyvio (vedolizumab), which the FDA has approved for moderate to severe Crohn's disease and ulcerative colitis. It's given at the dose on its approved label. Your first doses are IV infusions at the clinic, each about 30 minutes. After that you switch to a prefilled pen you use at home every 2 weeks. Our team gives your first pen dose at the clinic and shows you how.
Could I get a placebo?
No. Everyone in this study receives Entyvio. There is no placebo and no random assignment.
Who can join?
Adults 18 to 80 whose Crohn's disease was diagnosed with a colonoscopy and biopsy, and who still have moderate to severe symptoms after at least one of these didn't work well enough or caused side effects:
- Steroids, like prednisone
- An immune-suppressing medicine, like azathioprine, 6-MP or methotrexate
- A biologic or advanced medicine, like Humira, Remicade, Stelara, Skyrizi or Rinvoq
Some things rule people out, including having taken Entyvio before, more than 2 advanced medicines that didn't work, or having an ostomy. Our team will go over the full list with you on the phone.
I've already taken Entyvio. Can I join?
Not this study. Leave your number and we'll reach out if another study fits.
How long will the study last?
About 17 months in total: up to 4 weeks of screening, about a year on the medication, and a safety follow-up after your last dose. There are about 8 clinic visits in the first year, at the start and then at weeks 2, 6, 14, 26, 38 and 52. The final follow-up can be done by video or phone.
What tests are involved?
Blood draws, stool samples, physical exams and an ECG. You'll have a colonoscopy (or a shorter flexible sigmoidoscopy) during screening and again at about one year. For the first 14 weeks you'll also fill in a short daily symptom diary on your phone.
What if the medication isn't helping me?
At week 14 the study doctor checks how you're doing. If Entyvio isn't helping, you stop taking it, move to another treatment, and have a safety check-in about 18 weeks later.
Does it cost anything? Is there compensation?
No. The study medication, study visits and study tests are provided at no cost, no insurance is needed, and we provide free Uber rides to every visit. If you qualify and join, you may receive up to $525 in total for your time and travel to study visits.
Can I leave the study?
Yes. Taking part is voluntary. You can leave at any time, and it won't affect your regular medical care.
Have more questions about the study?
Call Our Friendly TeamEnrollment Is Open
It starts with a short call. Whether you join the study afterward is up to you.
No Cost to Participate
The study medication, study visits and study tests are provided at no cost to participants. No insurance is needed, and we provide free Uber rides to every visit.
No Obligation - Voluntary Participation
Answering the questions doesn't sign you up. Participation is completely voluntary and you may leave at any time. You decide if the study is right for you.
We use your information only to contact you about our studies. We never sell it.
Come Visit Us
Visit our clinic in Brooksville, FL, next to Oak Hill Hospital, for your study visits.
- Access Research Institute11373 Cortez Blvd Building C, Suite 200Brooksville, FL 34613Next to Oak Hill Hospital
- HoursMonday-Friday, 9am-5pm
- Call Now(352) 667-7237
- AccessibilityFree Uber rides to every visit
Free parking
Wheelchair accessible