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

Rheumatoid Arthritis Clinical Trial

— SWIFT  

Official title:

A Phase 3b, Open Label, Multicenter, Exploratory Study to Assess Changes in Joint Inflammation Using Ultrasonography in Subjects With Rheumatoid Arthritis Treated for 12 Weeks With Certolizumab Pegol

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01292265
• Other study ID #: RA0033
• Status: Terminated
• Phase: Phase 3
• Start date: February 2011
• Est. completion date: January 2012

Study information

• Verified date: October 2012
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
United States	7	Franklin	Wisconsin
United States	10	Los Angeles	California
United States	6	Rochester	New York
United States	1	Voorhees	New Jersey
United States	4	Walnut Creek	California
United States	8	Wheaton	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12		From Baseline (Week 0) to Week 12
Secondary	Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12		From Baseline (Week 0) to Week 12
Secondary	Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12		From Baseline (Week 0) to Week 12
Secondary	Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12		From Baseline (Week 0) to Week 12