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Monoclonal Antibodies
Tildrakizumab SC Injection for Psoriatic Arthritis
Phase 3
Waitlist Available
Research Sponsored by Sun Pharma Global FZE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 124
Awards & highlights
Study Summary
This trial is studying how well treatment with atezolizumab (MPDL3280A) works in patients with stage III non-small cell lung cancer.
Who is the study for?
This trial is for patients with Psoriatic Arthritis who completed a previous study without early discontinuation. Participants must understand the study requirements, agree to follow them, and provide written consent. Women of childbearing potential must abstain from sex or use dual contraception; pregnant or breastfeeding women are excluded.Check my eligibility
What is being tested?
The trial is testing Tildrakizumab injections in an open-label phase 3 setting to evaluate its long-term safety and effectiveness in treating Psoriatic Arthritis. Patients will receive subcutaneous injections as part of their treatment regimen.See study design
What are the potential side effects?
While specific side effects are not listed here, Tildrakizumab may cause reactions at the injection site, increase infection risk, and potentially lead to immune system-related issues due to its nature as an immunosuppressive drug.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 124
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 124
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and intensity of Adverse Events (AEs) recorded through the study period
Proportion of Subject Who Reached (American College of Rheumatology Score of 20) ACR20
Proportion of Subjects Who Reached (American College of Rheumatology Score of 50) ACR50
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TILD q12 weeksExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Sun Pharma Global FZELead Sponsor
33 Previous Clinical Trials
9,501 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
286 Patients Enrolled for Psoriatic Arthritis
Sun Pharmaceutical Industries LimitedLead Sponsor
64 Previous Clinical Trials
12,861 Total Patients Enrolled
1 Trials studying Psoriatic Arthritis
286 Patients Enrolled for Psoriatic Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have PsA and you met all the requirements for the main study, completed the treatment, and did not have to stop early for any reasons.You must agree to comply with the study restrictions, scheduled treatments, laboratory assessments, and other study proceduresI understand what participating in this study involves.I agree to either not have heterosexual sex or use two forms of birth control.I am not pregnant, breastfeeding, nor planning to during the study or up to 17 weeks after.
Research Study Groups:
This trial has the following groups:- Group 1: TILD q12 weeks
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- 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.
Psoriatic Arthritis Patient Testimony for trial: Trial Name: NCT04991116 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial being done at multiple sites within the state?
"There are a total of 29 clinical trial sites currently operational for this particular study. These include Sunpharma site no. 08 in Houston, Sunpharma site no. 13 in Baytown, and Sunpharma site no. 19 in Miami, as well as 26 other locations."
Answered by AI
Are researchers enrolling new participants in this clinical trial at this time?
"Unfortunately, this particular medical trial is not seeking patients at the moment. According to the latest update on clinicaltrials.gov (which was on May 6th, 2022), this trial is not actively recruiting. Although, there are other 386 trials that are currently looking for participants."
Answered by AI
Who else is applying?
What state do they live in?
Florida
Michigan
Texas
Other
How old are they?
65+
18 - 65
What site did they apply to?
Sunpharma site no. 05
Sunpharma site no. 10
Sunpharma site no. 09
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
I have tried very many different drugs and therapy to help my situation but nothing seems to work. I just want to be pain free and able to use my hand again. I would love to be able to go back to work. Someday soon hopefully.
PatientReceived 1 prior treatment
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