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Monoclonal Antibodies

Long-Term Safety of Tildrakizumab for Psoriatic Arthritis

Phase 2 & 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 upto week 208

Awards & highlights

Study Summary

This trial will show if a drug used to treat psoriatic arthritis is effective and safe when used long-term.

Who is the study for?

This trial is for individuals with Psoriatic Arthritis who completed a previous Tildrakizumab study. They must not have active tuberculosis, use certain arthritis medications together, or be on prohibited drugs. Participants need to consent and follow strict contraception guidelines if of childbearing potential.Check my eligibility

What is being tested?

The safety of long-term use of Tildrakizumab in treating Psoriatic Arthritis is being tested. This extension study requires participants from an earlier phase who are continuing treatment to assess ongoing effects and monitor any long-term side effects.See study design

What are the potential side effects?

While the specific side effects aren't listed here, generally such trials look out for allergic reactions, infection risks due to immune system changes, liver or kidney function alterations, and other drug-specific concerns over the extended period.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upto week 208

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upto week 208

This trial's timeline: 3 weeks for screening, Varies for treatment, and upto week 208 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with adverse events and its relationship to investigational medicinal product will be assessed by the Investigator (Global Introspection assessment)

Trial Design

3Treatment groups

Experimental Treatment

Group I: SUNPG18_07 q4 weeks, high doseExperimental Treatment2 Interventions

Group II: SUNPG18_07 q12 weeks, low doseExperimental Treatment1 Intervention

Group III: SUNPG18_07 q12 weeks, high doseExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SUNPG18_07 I

2018

Completed Phase 3

~290

SUNPG18_07 II

2018

Completed Phase 3

~290

SUNPG18_07 III

2018

Completed Phase 3

~290

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sun Pharma Global FZELead Sponsor

33 Previous Clinical Trials

9,865 Total Patients Enrolled

1 Trials studying Psoriatic Arthritis

650 Patients Enrolled for Psoriatic Arthritis

Sun Pharmaceutical Industries LimitedLead Sponsor

64 Previous Clinical Trials

13,225 Total Patients Enrolled

1 Trials studying Psoriatic Arthritis

650 Patients Enrolled for Psoriatic Arthritis

Media Library

Tildrakizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03552276 — Phase 2 & 3

Psoriatic Arthritis Research Study Groups: SUNPG18_07 q12 weeks, high dose, SUNPG18_07 q12 weeks, low dose, SUNPG18_07 q4 weeks, high dose

Psoriatic Arthritis Clinical Trial 2023: Tildrakizumab Highlights & Side Effects. Trial Name: NCT03552276 — Phase 2 & 3

Tildrakizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03552276 — Phase 2 & 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we still able to enroll new subjects for this research project?

"No, this particular study is not currently recruiting patients, as denoted on clinicaltrials.gov. This trial was first posted on July 11th 2018 and was last updated on August 26th 2020. There are, however, 384 other trials that are actively recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.

2018. "Long-Term Extension Trial of Tildrakizumab to Prove Its Safety in Subjects With Psoriatic Arthritis Who Have Previously Completed Study With Tildrakizumab.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03552276.