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Termination of study due to low enrollment. There were no safety issues.
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To evaluate the changes in joint inflammation produced by Cimzia over 12 week Treatment period measured by Power/Color Doppler and Gray scale Ultrasound.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| UCB Clinical Trial Call Center | +1 877 822 9493 (UCB) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 10 | Los Angeles | California | United States | |||
| 4 |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12 | From Baseline (Week 0) to Week 12 |
| 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline (Week 0) in the Modified Ultrasound-7 Joint (mUS7) Sumscore at Week 12 | Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. | Posted | From Baseline (Week 0) to Week 12 |
|
| ||||||||||||||||||||
| Secondary | Change From Baseline (Week 0) in the Clinical Disease Activity Index (CDAI) at Week 12 | Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. | Posted | From Baseline (Week 0) to Week 12 |
|
| ||||||||||||||||||||
| Secondary | Change From Baseline (Week 0) in C-reactive Protein (CRP) at Week 12 | Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. | Posted | From Baseline (Week 0) to Week 12 |
|
| ||||||||||||||||||||
| Secondary | Change From Baseline (Week 0) in Erythrocyte Sedimentation Rate (ESR) at Week 12 | Since only 3 subjects were enrolled in this study, the efficacy data is not interpretable and will not be presented. | Posted | From Baseline (Week 0) to Week 12 |
|
|
Adverse Events (AEs) were collected during the course of the trial, which was approximately 12 weeks per subject. Since only 3 subjects were enrolled in this study, only AE data will be summarized in a table, with frequency counts and percentages.
Adverse Events 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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 3 | 2 | 3 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Transaminases increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
|
UCB has > 60 but <= 180 days to review results communications prior to public release and may delete information that is confidential and compromises ongoing studies or is considered proprietary. This restriction is not intended to compromise the objective scientific integrity of the manuscript, it being understood that the results shall be published regardless of outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | UCB, Inc. | +1 887 822 9493 |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D018771 | Arthralgia |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000068582 | Certolizumab Pegol |
| ID | Term |
|---|---|
| D011092 | Polyethylene Glycols |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D007140 | Immunoglobulin Fab Fragments |
| D007128 | Immunoglobulin Fragments |
| D010446 | Peptide Fragments |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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