Rheumatoid Arthritis
Conditions
Keywords
Arthritis, Joint pain, Inflammation, Rheumatoid Arthritis
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.
Interventions
BIOLOGICALCertolizumab 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.
Sponsors
UCB Pharma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
United States
Participant flow
Recruitment details
This study started in February 2011. It was subsequently terminated due to low enrollment. Baseline characteristics refer to the Safety Set (SS). The Safety Set (SS) consisted of all patients included in this study receiving treatment with Certolizumab Pegol (CZP) at least once. There was a total of 3 subjects enrolled in this study.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | CZP 200 mg |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 44 years STANDARD_DEVIATION 4 |
| Region of Enrollment United States | 3 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
Primary
Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12
Time frame: From Baseline (Week 0) to Week 12
Population: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.
Secondary
Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Population: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.
Secondary
Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Population: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.
Secondary
Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12
Time frame: From Baseline (Week 0) to Week 12
Population: Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented.