Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2011-001443-74 | EudraCT Number |
Not provided
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Study is designed to show a lack of effect on white blood cells circulating in the spinal fluid.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Interventions prior to treatment. Control arm |
|
| Cohort 2 | Experimental | Interventions prior to and after 3 monthly injections |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lumbar puncture | Procedure | 2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF) | The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by fluorescence-activated cell sorting (FACS) for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle. | Baseline |
| Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3 | The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by FACS for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle. | Baseline, Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent for this measure are events between first dose of study drug and up to 85 days (Week 12) after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and non-serious AEs. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AKH Wien Universitaetsklinik fuer Innere Medizin III Klinische Abteilung fuer Gastroenterologie und | Vienna | 1090 | Austria | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28778448 | Derived | Stuve O, Cataldi F, Pradhan V, Gorelick KJ. Normal intrathecal leukocyte cell number and composition do not decrease the incidence of post-lumbar puncture headache. J Neuroimmunol. 2017 Sep 15;310:69-71. doi: 10.1016/j.jneuroim.2017.06.011. Epub 2017 Jun 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: PF-00547659 | Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| lumbar puncture | Drug | 1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses. |
|
| Baseline up to Week 12 |
| Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 | Serum samples were analysed for presence of ADAs to PF-00547659. Participants who showed positive results for PF-00547659 were reported. | Day 1; Weeks 4, 8, 9-11 (Cohort 2 only), 12, 20, 28, and 36; Early Withdrawal |
| Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity | Injection site reaction AEs include: injection site irritation, injection site pain, injection site rash, contusion, and erythema. | Baseline till End of Study/Early Withdrawal, up to Week 12 |
| Hopital Erasme |
| Brussels |
| B-1000 |
| Belgium |
| UZ Gasthuisberg | Leuven | B-3000 | Belgium |
| Hopital Cardiologique | Lille | 59037 | France |
| Hopital Huriez, CHRU de Lille | Lille | 59037 | France |
| Hopital Saint-Louis - CIC | Paris | 75010 | France |
| Hopital Saint-Louis | Paris | 75010 | France |
| Charité, Universitaetsmedizin Berlin, Campus Virchow Klinikum, | Berlin | 13353 | Germany |
| Academic Medical Center - University of Amsterdam, Dept. of Gastroenterology | Amsterdam | 1105 AZ | Netherlands |
| FG001 | Cohort 2: PF-00547659 | Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: PF-00547659 | Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite. |
| BG001 | Cohort 2: PF-00547659 | Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | 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 | Cohort 2: Baseline Absolute Lymphocyte Count in Cerebrospinal Fluid (CSF) | The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by fluorescence-activated cell sorting (FACS) for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle. | All Cohort 2 participants who were enrolled, had 2 evaluable LPs, and who received all 3 doses of study drug. | Posted | Median | Full Range | cells per milliliter (cells/mL) | Baseline |
|
|
| |||||||||||||||||||||||||
| Primary | Cohort 2: Percent Change From Baseline in Absolute Lymphocyte Count in CSF at Month 3 | The primary CSF endpoint of Cohort 2 was the percent change from baseline in absolute lymphocyte counts in CSF after 3 doses of PF-00547659. The hypothesis for the primary endpoint was evaluated using the CSF evaluable population in Cohort 2. CSF samples were obtained via lumbar puncture and analyzed by FACS for total lymphocyte counts. Lumbar punctures were performed by a highly qualified physician using a 20-22 gauge needle, preferably an atraumatic needle. | All Cohort 2 participants who were enrolled, had 2 evaluable lumbar punctures, and who received all 3 doses of study drug. | Posted | Median | Full Range | percent change | Baseline, Month 3 |
|
| ||||||||||||||||||||||||||
| Secondary | Cohorts 1 and 2: Total Number of Participants With Non-Lumbar Puncture (LP) Related Treatment-Emergent Adverse Events (AEs), Withdrawals Due to AEs, and Serious Adverse Events (SAEs) During the 12-week Treatment Period | An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly/birth defect. Treatment-emergent for this measure are events between first dose of study drug and up to 85 days (Week 12) after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included serious and non-serious AEs. | All participants who received at least one dose of study drug were analyzed for AEs/safety. Combined data for both cohorts is presented. | Posted | Number | participants | Baseline up to Week 12 |
| ||||||||||||||||||||||||||||
| Secondary | Cohorts 1 and 2: Number of Participants Who Developed Anti-Drug Antibodies (ADAs) to PF-00547659 | Serum samples were analysed for presence of ADAs to PF-00547659. Participants who showed positive results for PF-00547659 were reported. | All participants who received at least one dose of study drug. | Posted | Number | participants | Day 1; Weeks 4, 8, 9-11 (Cohort 2 only), 12, 20, 28, and 36; Early Withdrawal |
| ||||||||||||||||||||||||||||
| Secondary | Cohorts 1 and 2: Number of Participants With Injection Site Reactions by Severity | Injection site reaction AEs include: injection site irritation, injection site pain, injection site rash, contusion, and erythema. | All participants who received at least one dose of study drug. | Posted | Number | participants | Baseline till End of Study/Early Withdrawal, up to Week 12 |
|
Screening till end of study or at early withdrawal, whichever was earlier, up to Week 12.
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: PF-00547659 | Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite. | 1 | 10 | 9 | 10 | ||
| EG001 | Cohort 2: PF-00547659 | Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite. | 3 | 39 | 37 | 39 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Crohn's disease | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Enterocutaneous fistula | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anorectal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Crohn's disease | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ileal stenosis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Perianal erythema | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Proctalgia | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Injection site irritation | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Injection site rash | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Celluliitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Clostridium difficile infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eye infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Herpes ophthalmic | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Laryngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Stoma site abscess | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Wound complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Iron deficiency | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Polydipsia | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Zinc deficiency | Metabolism and nutrition disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Bone swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fistula | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cervicobrachial syndrome | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Restless legs syndrome | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Burnout syndrome | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nervousness | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Panic attack | Psychiatric disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Renal pain | Renal and urinary disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Perineal erythema | Reproductive system and breast disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Erythema nodosum | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nail pitting | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D007079 | Ileitis |
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D004751 | Enteritis |
| D007077 | Ileal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013129 | Spinal Puncture |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003943 | Diagnostic Techniques, Neurological |
| D011677 | Punctures |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
Not provided
Not provided
| 45-64 years |
|
| More than or equal to (>=) 65 years |
|
| Male |
|
|
|
|
Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite. |
|
|
|
|
|
|