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

NCT01292265 | Terminated Phase 3 Results

• 1 other identifier: RA0033
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 6

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.

Conditions

Rheumatoid Arthritis

Keywords

Arthritis; Joint pain; Inflammation; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12

  From Baseline (Week 0) to Week 12

Secondary Outcomes (3)

• Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12

  From Baseline (Week 0) to Week 12

• Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12

  From Baseline (Week 0) to Week 12

• Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12

  From Baseline (Week 0) to Week 12

Study Arms (1)

CZP 200 mg

EXPERIMENTAL

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.

Biological: Certolizumab Pegol

Interventions

Certolizumab Pegol 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.

Also known as: Cimzia, CZP

CZP 200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (6)

10

Los Angeles, California, United States

Location

4

Walnut Creek, California, United States

Location

8

Wheaton, Maryland, United States

Location

1

Voorhees Township, New Jersey, United States

Location

6

Rochester, New York, United States

Location

7

Franklin, Wisconsin, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Arthritis; Arthralgia; Inflammation

Interventions

Certolizumab Pegol

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Polyethylene Glycols; Polymers; Macromolecular Substances; Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: UCB, Inc.

+1 887 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: February 7, 2011
• First Posted: February 9, 2011
• Study Start: February 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: August 1, 2018
• Results First Posted: December 5, 2012

Record last verified: 2012-10

Locations

US (6)