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Cohort 1 for Rheumatoid Arthritis

Phase 1

Waitlist Available

Research Sponsored by Teijin America, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through day 10

Awards & highlights

Study Summary

This trial will test the safety and effectiveness of a new drug for treating rheumatoid arthritis.

Eligible Conditions

Rheumatoid Arthritis

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 10 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 patients with adverse events (AEs) and adverse event of special interest (AESI)

Secondary outcome measures

AUC0-inf: Area under the plasma concentration-time curve from pre-dose (time 0) extrapolated to infinite time

AUC0-t: Area under the plasma concentration-time curve up to last measurable concentration

AUCtau: Area under the plasma concentration-time curve over a dosing interval, tau = 24 hours

+15 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 4Experimental Treatment2 Interventions

The patient will receive Dose D of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).

Group II: Cohort 3Experimental Treatment2 Interventions

The patient will receive Dose C of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).

Group III: Cohort 2Experimental Treatment2 Interventions

The patient will receive Dose B of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).

Group IV: Cohort 1Experimental Treatment2 Interventions

The patient will receive Dose A of TCK-276 or matching placebo orally from Day 1 to Day 7 (once daily (QD) under fed conditions).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TCK-276

2022

Completed Phase 1

~40

TCK-276 Placebo

2022

Completed Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Teijin America, Inc.Lead Sponsor

2 Previous Clinical Trials

154 Total Patients Enrolled

ParexelIndustry Sponsor

303 Previous Clinical Trials

100,794 Total Patients Enrolled

7 Trials studying Rheumatoid Arthritis

1,747 Patients Enrolled for Rheumatoid Arthritis

Tatyana ZubkovskayaStudy DirectorMedical Director

Frequently Asked Questions

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

Has Cohort 1 been given the greenlight by the FDA?

"Limited data on safety and efficacy means that Cohort 1 has been assigned a score of 1."

Answered by AI

Are participants aged 20 or older eligible to join this trial?

"This investigation is seeking candidates of legal age who are younger than 64 years old."

Answered by AI

Are additional participants being actively sought for this experiment?

"Indeed, the details posted to clinicaltrials.gov are indicative of this medical trial actively recruiting patients which first became available on August 10th 2022 and was recently updated November 23rd 2022. A total of 32 individuals need to be recruited from across 5 distinct sites in order for the study to proceed."

Answered by AI

To whom is enrollment in this research project open?

"This clinical trial seeks 32 patients with a diagnosis of rheumatoid arthritis (RA) who are aged between 18 and 64. Vital eligibility criteria include: Accurately fitting the 2010 American College of Rheumatology/European League Against Rheumatism classification for RA, Non-childbearing potential or FSH > 40 U/mL at screening visit, Abstinence from nicotine products evidenced by urine cotinine concentration, Permitted concomitant medications on stable dose including anti-malarials; NSAIDs including selective cyclooxygenase-2 inhibitors; methotrexate + folic acid / folinic acid"

Answered by AI

What is the current participant count for this research project?

"Affirmative. According to details provided on clinicaltrials.gov, this medical experiment initially published on August 10th 2022 is currently recruiting individuals for participation. 32 volunteers are required across 5 different research facilities."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis

2022. "A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Oral Doses of TCK-276 in Patients With Rheumatoid Arthritis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05437419.