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COMPLETEDPHASE1

Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs

A Randomized, Double-blind, Parallel, Vehicle Controlled, Repeat Dose Comparative Phase 1b Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ORTD-1 in Rheumatoid Arthritis Patients With Mild Disease Managed With DMARDs

NCT04286789•Oryn Therapeutics, LLC

View on ClinicalTrials.gov

Summary

This is a randomized, vehicle controlled, double-blind, repeat dose comparative study in patients with rheumatoid arthritis (RA) under management with DMARDs and with persistent disease activity. The goal of this study is to evaluate the safety, tolerability and pharmacokinetics of 6 weekly repeat doses of ORTD-1.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•≥18 years of age or older, males or females.
•Diagnosed rheumatoid arthritis per the American Rheumatism Association 1987 classification criteria of at least 6 months duration.
•Disease activity defined as:
•* erythrocyte sedimentation rate (ESR) \> 24 mm or serum C-reactive protein level ≥ 1.2 times (X) the upper limit of normal (ULN), and
•* DAS28-CRP score ≥ 2.6 and \< 5.1
•Current regimen of DMARDs that may include methotrexate, sulfasalazine, hydroxychloroquine, leflunomide and/or azathioprine, alone or in combination.
•No change in DMARD dose(s) within 4 weeks prior to Screening.
•May be receiving a stable regimen (of at least 4 weeks duration) of concomitant NSAIDs.
•Women of child-bearing potential (WOCBP), defined as a sexually mature woman not surgically sterilized, or not post-menopausal for at least 12 consecutive months. Female subjects must:
•* Not be lactating; not be pregnant upon enrollment.
+6 more criteria

Exclusion Criteria

•Prior therapy with any biologic therapeutic within 3 months prior to enrollment, or in the case of Rituxan (rituximab), this period must be at least 12 months.
•History of or current clinical fibromyalgia or Juvenile Idiopathic Arthritis (JIA).
•Positive diagnosis of SLE.
•Patients with Type 1 or Type 2 Diabetes Mellitus.
•Patients with psoriasis.
•Patients with skin condition(s) or visible abnormalities at or near potential sites of injection (right and left abdomen; right and left thigh) that could mask the assessment of safety.
•Acute illness including current or chronic infections requiring antibiotics, or symptoms of a resolving illness, within 2 weeks prior to study.
•Any investigational drug within 3 months prior to study.
•Patients may not be receiving systemic corticosteroid therapy with the exception of inhaled corticosteroids for the treatment of asthma.
•Any clinically relevant abnormality as assessed by the Investigator, on screening history, physical exam, clinical laboratory, chest X-ray, or ECG, other than values consistent with rheumatoid arthritis, with the exception that liver function tests (ALP, ALT, AST) may be up to 1.5 times (X) the upper limit of normal (ULN).
+7 more criteria

Locations (3)

Keck School of Medicine of USC Division of Rheumatology

Los Angeles, California, United States

Orange County Research Center

Tustin, California, United States

Advanced Pharma CR, LLC

Miami, Florida, United States

Key Dates

Start Date

March 22, 2021

Primary Completion Date

October 12, 2021

Completion Date

October 12, 2021

Last Updated

October 19, 2021

Enrollment

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

Low dose ORTD-1

DRUG

Low dose vehicle control

DRUG

High dose ORTD-1

DRUG

High dose vehicle control

DRUG

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

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Rheumatoid Arthritis (RA)Rheumatoid Arthritis-Associated Interstitial Lung Disease+1 more

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RECRUITINGPHASE1

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 19, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Randomized, Double-blind, Vehicle Controlled, Repeat Dose Comparative Study in RA Patients Managed With DMARDs

Inclusion Criteria

Exclusion Criteria

Clinical Cohort Construction and Therapeutic Effect Evaluation of Integrated Traditional Chinese and Western Medicine in the Treatment of Rheumatoid Arthritis

A Study to Evaluate the Safety and Activity of SAR448501/DR-0201 in Patients With Autoimmune Rheumatic Diseases

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