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| Name | Class |
|---|---|
| Centocor BV | INDUSTRY |
The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients with Multiple Sclerosis
Multiple sclerosis (MS) is a life-long disease that usually starts in young adults. In MS, inflammation and damage to nerve cells occur in the brain and spinal cord. Symptoms of MS are quite variable and may range from being mild to severe and from short to long lasting. People with MS may have a wide variety of symptoms ranging from mild to disabling. Some of thesymptoms of MS include visual disturbances such as double vision, weakness in arms or legs,difficulty with coordination, fatigue, changes in sensations such as numbness and tingling, or difficulties with concentration or memory.The drug being tested in this research study is an antibody called CNTO 1275. Antibodies are natural substances made by the body that stick to and react with other substances in the body that may cause diseases. The body makes antibodies mainly to fight infections. CNTO 1275 is an antibody that has been manufactured in the laboratory. In the test tube, CNTO 1275 sticks to and blocks the activity of a naturally occurring substance in the body called interleukin 12 (IL-12).Higher than normal levels of IL-12 have been found in people who have MS. CNTO 1275 has been tested in animals with a condition similar to MS. In those animals, IL-12 was over-produced.Animals treated with CNTO 1275 showed decreased symptoms of the condition.The purpose of this study is to better understand the safety and effectiveness of CNTO 1275 in people who have relapsing-remitting MS
Patients will receive subcutaneous injections of 30, 100, 200 mg of CNTO 1275 or placebo at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 or 100 mgs at weeks 0,1,2,3,11 and 19 and placebo at wks 7 and 15.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CNTO 1275 | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23. | A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan. | Week 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Relapses of Multiple Sclerosis (MS) Through Week 23 | Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS. | Week 23 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Centocor, Inc. Clinical Trial | Centocor, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19317608 | Derived | Robinson D Jr, Zhao N, Gathany T, Kim LL, Cella D, Revicki D. Health perceptions and clinical characteristics of relapsing-remitting multiple sclerosis patients: baseline data from an international clinical trial. Curr Med Res Opin. 2009 May;25(5):1121-30. doi: 10.1185/03007990902797675. | |
| 18703004 | Derived |
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A total of 249 patients were enrolled in the trial to receive either placebo or ustekinumab (CNTO 1275). There were 38 investigative sites in North America, Europe and Australia.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group I: Placebo | Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 |
| FG001 | Group II: Ustekinumab 27 mg Every 4 Weeks | Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
| FG002 | Group III: Ustekinumab 90 mg Every 8 Weeks | Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15. |
| FG003 | Group IV: Ustekinumab 90 mg Every 4 Weeks | Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
| FG004 | Group V: Ustekinumab 180 mg Every 4 Weeks | Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group I: Placebo | Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 |
| BG001 | Group II: Ustekinumab 27 mg Every 4 Weeks | Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23. | A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan. | Intent to treat. Missing data was imputed. The average number of newly Gd enhancing T1-weighted lesions from all valid visits for the patient will be used when prohibited medications are initiated. | Posted | Median | Inter-Quartile Range | Lesions | Week 23 |
|
71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
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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 | Group I: Placebo | Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
The count of patients with any nonserious adverse events (NAE) excludes patients who only had NAE that occurred in <=5% of patients. This information may vary from existing approved labeling and publications due to the requirement of this website.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Dir. Clinical Research | Centocor Research & Development, Inc. | 1-800-457-6399 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000069549 | Ustekinumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Change From Baseline in Expanded Disability Status Scale (EDSS) | The EDSS is based on an independent neurologist's examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10. | Baseline, Week 23 |
| Segal BM, Constantinescu CS, Raychaudhuri A, Kim L, Fidelus-Gort R, Kasper LH; Ustekinumab MS Investigators. Repeated subcutaneous injections of IL12/23 p40 neutralising antibody, ustekinumab, in patients with relapsing-remitting multiple sclerosis: a phase II, double-blind, placebo-controlled, randomised, dose-ranging study. Lancet Neurol. 2008 Sep;7(9):796-804. doi: 10.1016/S1474-4422(08)70173-X. |
| Lost to Follow-up |
|
| Other |
|
| BG002 | Group III: Ustekinumab 90 mg Every 8 Weeks | Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15. |
| BG003 | Group IV: Ustekinumab 90 mg Every 4 Weeks | Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
| BG004 | Group V: Ustekinumab 180 mg Every 4 Weeks | Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
| BG005 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
| OG002 | Group III: Ustekinumab 90 mg Every 8 Weeks | Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15. |
| OG003 | Group IV: Ustekinumab 90 mg Every 4 Weeks | Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
| OG004 | Group V: Ustekinumab 180 mg Every 4 Weeks | Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. |
|
|
|
| Secondary | Relapses of Multiple Sclerosis (MS) Through Week 23 | Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS. | Missing data remained missing. No treatment failure rule was implemented. | Posted | Median | Inter-Quartile Range | Relapses | Week 23 |
|
|
|
|
| Secondary | Change From Baseline in Expanded Disability Status Scale (EDSS) | The EDSS is based on an independent neurologist's examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10. | Intent to treat. Missing data was imputed. Missing EDSS scores was replaced with the last non-missing EDSS value observed (last observation carried forward). | Posted | Median | Inter-Quartile Range | Units on a scale | Baseline, Week 23 |
|
|
|
|
| 1 |
| 49 |
| 31 |
| 49 |
| EG001 | Group II: Ustekinumab 27 mg Every 4 Weeks | Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. | 3 | 51 | 35 | 51 |
| EG002 | Group III: Ustekinumab 90 mg Every 8 Weeks | Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15. | 0 | 47 | 34 | 47 |
| EG003 | Group IV: Ustekinumab 90 mg Every 4 Weeks | Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. | 2 | 52 | 38 | 52 |
| EG004 | Group V: Ustekinumab 180 mg Every 4 Weeks | Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19. | 1 | 50 | 44 | 50 |
| Tonsil cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site rash | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Injection site bruising | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 9.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 9.0 | Systematic Assessment |
|
| Vision blurred | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 9.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
|
Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| 95 |
| No |
| Superiority or Other |
| 2-sided Wilcoxon Mann-Whitney | 0.517 | 95 | No | Superiority or Other |
| Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group. | 2-sided Wilcoxon Mann-Whitney | 0.967 | 95 | No | Superiority or Other |
2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo
| 0.152 |
| 95 |
| No |
| Superiority or Other |
| Wilcoxon (Mann-Whitney) | 2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo | 0.431 | 95 | No | Superiority or Other |
| Hypothesis: The null hypothesis is no difference between any ustekinumab treatment groups and placebo at a significant level of 0.05 for comparison for each treatment group with placebo.. | Wilcoxon (Mann-Whitney) | 2-sided Wilcoxon Mann-Whitney test (α = 0.05) used for each comparison with placebo | 0.292 | 95 | No | Superiority or Other |