A 12 Week Study to Assess Changes in Joint Inflammation Using Ultrasonography in Patients With Rheumatoid Arthritis (RA)

NCT ID: NCT01292265

Last Updated: 2018-08-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2012-01-31

Brief Summary

To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.

Detailed Description

Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. Only Adverse Event (AE) data will be summarized in a table, with frequency counts and percentages.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CZP 200 mg

Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.

Group Type: EXPERIMENTAL

Certolizumab Pegol

Intervention Type: BIOLOGICAL

Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.

Interventions

Certolizumab Pegol

Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.

Intervention Type: BIOLOGICAL

Other Intervention Names

Cimzia; CZP

Eligibility Criteria

Inclusion Criteria

• Diagnosed with adult-onset Rheumatoid Arthritis (RA) >6 months and <3 years
• Active RA
• Must have failed at least one disease modifying Anti Rheumatic Drug (DMARD) treatment
• Subject can have attempted no more than one previous Anti Tumor Necrosis factor (anti-TNF) and discontinued due to drug intolerance

Exclusion Criteria

• Subject cannot have a second non-inflammatory musculoskeletal condition
• Subject cannot have a diagnosis of any other inflammatory arthritis
• Subject cannot have any previously infected prosthesis
• Subject cannot have arthroplasties in any of the joints assessed in the study
• Subject cannot have a history of chronic infections
• Subject cannot have known Tuberculosis (TB) disease, high risk of acquiring TB, or latent TB infection
• Subject cannot have a history of or current Lymphoproliferative disorder
• Subject cannot have known Human Immunodeficiency Virus (HIV) infection
• Subject cannot have received a live or attenuated vaccine within 8 weeks
• Subject cannot have current or history of malignancy
• Subject cannot have a history of blood disorders
• Subject cannot have a current or recent history of severe, progressive, and/or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
• Subjects must not have a history of adverse reaction to Polyethylene glycol (PEG), a protein medicinal product, or ultrasound gel applied to the skin

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877 822 9493 (UCB)

Locations

10

Los Angeles, California, United States

4

Walnut Creek, California, United States

8

Wheaton, Maryland, United States

1

Voorhees Township, New Jersey, United States

6

Rochester, New York, United States

7

Franklin, Wisconsin, United States

Countries

United States

Other Identifiers

RA0033

Identifier Type: -

Identifier Source: org_study_id