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

Study Overview
=================
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.

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

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Biological: Certolizumab Pegol


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CZP 200 mg<br>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<br>* 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.<br>* Other names: CZP;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12 |  | From Baseline (Week 0) to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Joint pain, Inflammation, Rheumatoid Arthritis