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A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

NCT00888745•Genentech, Inc.

View on ClinicalTrials.gov

Summary

This is a Phase I multicenter study that will be conducted in the United States and Europe.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•RA diagnosed according to the American College of Rheumatology (ACR)

Exclusion Criteria

•Female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
•Clinically significant abnormal ECG
•History of anaphylactic reactions
•Positive hepatitis C antibody or hepatitis B surface antigen
•Positive serology for human immunodeficiency virus (HIV) by quantitative polymerase chain reaction
•A history of an autoimmune disease other than RA (other than secondary Sjogren syndrome)
•Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty syndrome
•Malignancy, or prior malignancy, other than non-melanoma skin cancer, or cervical carcinoma in situ that has been resected
•Recent administration of a live, attenuated vaccine, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
•Concomitant therapy with a biologic agent
+3 more criteria

Locations (12)

Investigational Site

Anniston, Alabama, United States

Investigational Site

Orlando, Florida, United States

Investigational Site

Ormond Beach, Florida, United States

Investigational Site

Palm Harbor, Florida, United States

Investigational Site

Idaho Falls, Idaho, United States

Investigational Site

Indianapolis, Indiana, United States

Investigational Site

Frederick, Maryland, United States

Investigational Site

Oklahoma City, Oklahoma, United States

Investigational Site

Duncansville, Pennsylvania, United States

Investigational Site

Budapest, Hungary

Key Dates

Start Date

May 1, 2009

Primary Completion Date

June 1, 2010

Last Updated

December 1, 2010

Enrollment

ACTUAL participants

Conditions

Rheumatoid Arthritis

Interventions

placebo

DRUG

PRO283698

DRUG

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

NCT06647069

Systemic Lupus Erythematosus (SLE)Rheumatoid Arthritis (RA)

View study

RECRUITING

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

NCT07484243

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

View study

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: December 1, 2010Data 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.

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A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis

Inclusion Criteria

Exclusion Criteria

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

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

Targeted Remotely-delivered Anti-inflammatory Interventions With Exercise for Rheumatoid Arthritis

Plant-Based Diet for Patients With Rheumatoid Arthritis

An Ascending Dose Study of PIT565 in Participants With Rheumatoid Arthritis

A Phase II Trial of SHR-3045 Injection in Patients With Rheumatoid Arthritis