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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-003647-19 | EudraCT Number |
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This study is designed to evaluate the efficacy and safety of AMG 714 for the attenuation of the effects of gluten exposure in adult patients with celiac disease during a gluten challenge.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AMG 714 150 mg | Experimental | Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
|
| AMG 714 300 mg | Experimental | Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
|
| Placebo | Placebo Comparator | Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AMG 714 | Biological | AMG 714 administered by subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 | Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist. | Baseline and week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12 | Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased intraepithelial lymphocytes is associated with celiac disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Amgen, MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ODL | Oulu | Finland | ||||
| Tampere University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41039829 | Derived | Zhang X, Jia L, Lin X, Zhou L. Exhaustion-Resistant CD8 + T Cells in Ankylosing Spondylitis: A Proposed Three-Axis Model. Immunology. 2025 Dec;176(4):409-420. doi: 10.1111/imm.70044. Epub 2025 Oct 2. | |
| 31494096 | Derived | Lahdeaho ML, Scheinin M, Vuotikka P, Taavela J, Popp A, Laukkarinen J, Koffert J, Koivurova OP, Pesu M, Kivela L, Lovro Z, Keisala J, Isola J, Parnes JR, Leon F, Maki M. Safety and efficacy of AMG 714 in adults with coeliac disease exposed to gluten challenge: a phase 2a, randomised, double-blind, placebo-controlled study. Lancet Gastroenterol Hepatol. 2019 Dec;4(12):948-959. doi: 10.1016/S2468-1253(19)30264-X. Epub 2019 Sep 4. |
| Label | URL |
|---|---|
| Related Info | View source |
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Publication in peer-reviewed journal
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Participants who met the study entry criteria were randomized at a 1:1:1 ratio to receive 150 mg or 300 mg AMG 714 or placebo once every 2 weeks for a total of 6 administrations over a period of 10 weeks. Randomization was stratified by study site and sex.
This study was conducted at three sites in Finland.
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| ID | Title | Description |
|---|---|---|
| FG000 | AMG 714 150 mg | Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| FG001 | AMG 714 300 mg | Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| FG002 | Placebo | Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | AMG 714 150 mg | Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| BG001 |
| 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 | Percent Change From Baseline in Villous Height to Crypt Depth Ratio (VH:CD) at Week 12 | Attenuation of the effects of gluten exposure was assessed by measuring the percent change from baseline in villous height to crypt depth ratio after 10 weeks of gluten challenge. Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease. A decreased VH:CD ratio indicates worsening disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist. | The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and week 12 |
|
From first dose of study drug until week 16
Not provided
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 | 150 mg AMG 714 | Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 | medinfo@amgen.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 29, 2016 | Nov 14, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 19, 2017 | Nov 14, 2019 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D002446 | Celiac Disease |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000706949 | AMG-714 |
Not provided
Not provided
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| Placebo | Biological | Matching placebo to AMG 714 administered by subcutaneous injection |
|
| Placebo Gluten Challenge | Other | Gluten-free cookies (Finnish rusks) |
|
| Gluten Challenge | Other | Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving |
|
| Baseline and week 12 |
| Number of Participants With Improvement in Marsh Score at Week 12 | The Marsh classification system describes the stages of damage in the small intestine as seen under a microscope, with possible values of 0, 1, 2, 3a, 3b, or 3c. A score of 0 (best score) indicates that the intestinal lining is normal and celiac disease highly unlikely, a score of 3c (worst score) indicates increased intraepithelial lymphocytes, increased crypt hyperplasia and complete villi atrophy. Improvement is defined as a lower grade on the Marsh score scale compared to baseline. | Baseline and week 12 |
| Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12 | Levels of anti-tTG IgA antibodies in serum were determined using an enzyme-linked immunosorbent assay (ELISA) immunoassay. | Baseline and week 12 |
| Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12 | Levels of serum anti-DGP antibodies (immunoglobulin A [IgA] and immunoglobulin G [IgG]) were determined using ELISA immunoassay. | Baseline and week 12 |
| Number of Weekly Bowel Movements at Baseline and Week 12 | Participants were asked to record every bowel movement during the study using an electronic diary. If no bowel movements were experienced on any given day, the participant was required to document this using the electronic diary. | Baseline and week 12 |
| Number of Participants With Diarrhoea at Baseline and Week 12 | The Bristol Stool Form Scale (BSFS) is a pictorial aid to help study participants identify the shape and consistency of their bowel movements. Participants were asked to complete this form daily using an electronic diary at the time of each bowel movement. The BSFS categorizes bowel movements into 7 types, from Type 1 (separate hard lumps, like nuts; hard to pass) to Type 7 (watery, no solid pieces, entirely liquid). Diarrhoea was defined as at least one BSFS score >= 6 for the given week. | Baseline and week 12 |
| Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12 | The GSRS is a 15-question 7-scale questionnaire used to assess 5 dimensions of gastrointestinal syndromes: diarrhea, indigestion, constipation, abdominal pain, and reflux. Questions are scored between 1 (no discomfort at all) and 7 (very severe discomfort). The total GSRS score is calculated as the sum of the scores of all 15 questions, and ranges from 15 (no discomfort at all) to 105 (very severe discomfort in all 5 dimensions of gastrointestinal syndromes). | Baseline and 12 weeks |
| Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12 | The CeD-GSRS score is derived from a subset of questions from the GSRS questionnaire, including the diarrhea, indigestion, and abdominal pain domains (a total of 10 questions), which are each assessed on a scale of 1 (no discomfort at all) to 7 (very severe discomfort). The total CeD-GSRS score is calculated as the sum of the scores of all 10 questions, and ranges from 10 (no discomfort at all) to 70 (very severe discomfort in all celiac syndromes). | Baseline and 12 weeks |
| Tampere |
| Finland |
| CRST | Turku | Finland |
| AMG 714 300 mg |
Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| BG002 | Placebo | Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Small Intestinal Villous Height to Crypt Depth Ratio | Villi are the small fingerlike projections that line the small intestine and promote nutrient absorption and are often shortened in patients with celiac disease. Crypts are grooves between the villi that are often elongated in patients with celiac disease (crypt hyperplasia). A lower villous height to crypt depth ratio (VH:CD) indicates a flattening of the mucosa and more severe intestinal injury. | The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy samples) and received gluten challenge for at least 1 week. | Mean | Standard Deviation | ratio |
|
| AMG 714 150 mg |
Participants received 150 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| OG001 | AMG 714 300 mg | Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
| OG002 | Placebo | Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). |
|
|
|
| Secondary | Percent Change From Baseline in Intraepithelial Lymphocyte Density at Week 12 | Intraepithelial lymphocytes (IELS) are white blood cells interspersed between epithelial cells of the small and large intestine where they function to preserve the integrity of the mucosal barrier by protecting the epithelium against pathogen or immune-induced pathology. Increased intraepithelial lymphocytes is associated with celiac disease. Small bowel biopsies were performed at baseline and week 12; histological assessments were performed by a blinded central pathologist. | The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week. | Posted | Least Squares Mean | Standard Error | percent change | Baseline and week 12 |
|
|
|
|
| Secondary | Number of Participants With Improvement in Marsh Score at Week 12 | The Marsh classification system describes the stages of damage in the small intestine as seen under a microscope, with possible values of 0, 1, 2, 3a, 3b, or 3c. A score of 0 (best score) indicates that the intestinal lining is normal and celiac disease highly unlikely, a score of 3c (worst score) indicates increased intraepithelial lymphocytes, increased crypt hyperplasia and complete villi atrophy. Improvement is defined as a lower grade on the Marsh score scale compared to baseline. | The per protocol 1 (PP1) population included randomized participants who received at least 1 dose of study drug, were histologically evaluable (provided a post-treatment biopsy sample) and received gluten challenge for at least 1 week. | Posted | Count of Participants | Participants | Baseline and week 12 |
|
|
|
| Secondary | Percent Change From Baseline in Anti-Tissue Transglutaminase (tTG) Immunoglobulin A (IgA) Antibodies at Week 12 | Levels of anti-tTG IgA antibodies in serum were determined using an enzyme-linked immunosorbent assay (ELISA) immunoassay. | Per protocol 1 population with available data | Posted | Least Squares Mean | Standard Error | percent change | Baseline and week 12 |
|
|
|
|
| Secondary | Change From Baseline in Anti-Deamidated Gliadin Peptide (DGP) Antibodies at Week 12 | Levels of serum anti-DGP antibodies (immunoglobulin A [IgA] and immunoglobulin G [IgG]) were determined using ELISA immunoassay. | Per protocol 1 population with available data | Posted | Least Squares Mean | Standard Error | kU/L | Baseline and week 12 |
|
|
|
|
| Secondary | Number of Weekly Bowel Movements at Baseline and Week 12 | Participants were asked to record every bowel movement during the study using an electronic diary. If no bowel movements were experienced on any given day, the participant was required to document this using the electronic diary. | Per protocol 1 population with available data | Posted | Mean | Standard Deviation | bowel movements per week | Baseline and week 12 |
|
|
|
|
| Secondary | Number of Participants With Diarrhoea at Baseline and Week 12 | The Bristol Stool Form Scale (BSFS) is a pictorial aid to help study participants identify the shape and consistency of their bowel movements. Participants were asked to complete this form daily using an electronic diary at the time of each bowel movement. The BSFS categorizes bowel movements into 7 types, from Type 1 (separate hard lumps, like nuts; hard to pass) to Type 7 (watery, no solid pieces, entirely liquid). Diarrhoea was defined as at least one BSFS score >= 6 for the given week. | Per protocol 1 population | Posted | Count of Participants | Participants | Baseline and week 12 |
|
|
|
| Secondary | Percent Change From Baseline in Total Weekly Gastrointestinal Symptom Rating Scale (GSRS) Score at Week 12 | The GSRS is a 15-question 7-scale questionnaire used to assess 5 dimensions of gastrointestinal syndromes: diarrhea, indigestion, constipation, abdominal pain, and reflux. Questions are scored between 1 (no discomfort at all) and 7 (very severe discomfort). The total GSRS score is calculated as the sum of the scores of all 15 questions, and ranges from 15 (no discomfort at all) to 105 (very severe discomfort in all 5 dimensions of gastrointestinal syndromes). | Per protocol 1 population with available data | Posted | Least Squares Mean | Standard Error | percent change | Baseline and 12 weeks |
|
|
|
|
| Secondary | Change From Baseline in Total Celiac Disease GSRS (CeD-GSRS) Score at Week 12 | The CeD-GSRS score is derived from a subset of questions from the GSRS questionnaire, including the diarrhea, indigestion, and abdominal pain domains (a total of 10 questions), which are each assessed on a scale of 1 (no discomfort at all) to 7 (very severe discomfort). The total CeD-GSRS score is calculated as the sum of the scores of all 10 questions, and ranges from 10 (no discomfort at all) to 70 (very severe discomfort in all celiac syndromes). | Per protocol 1 population with available data | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and 12 weeks |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 21 |
| 22 |
| EG001 | 300 mg AMG 714 | Participants received 300 mg AMG 714 via subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). | 0 | 21 | 0 | 21 | 20 | 21 |
| EG002 | Placebo | Participants received placebo subcutaneous injection once every 2 weeks for a total of 6 doses over 10 weeks from day 0. Participants received gluten-free cookies twice a day for the first 2 weeks and gluten-containing cookies twice a day from weeks 2 to 12 (gluten-challenge). | 0 | 19 | 0 | 19 | 19 | 19 |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | MedDRA 18.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Photopsia | Eye disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Faeces soft | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Frequent bowel movements | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrointestinal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lip blister | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oesophagitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oral disorder | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Regurgitation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tongue disorder | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tongue eruption | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Mucosal dryness | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Gingivitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Procedural headache | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood albumin decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood albumin increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood calcium increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood phosphorus increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Blood potassium increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Body temperature decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| White blood cell count increased | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| White blood cells urine positive | Investigations | MedDRA 18.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Polyneuropathy | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vulvovaginal dryness | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Vulvovaginal pruritus | Reproductive system and breast disorders | MedDRA 18.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pharyngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Tonsillolith | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
|
| Lipoma excision | Surgical and medical procedures | MedDRA 18.1 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
| Temporal arteritis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| ≥ 65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
The model included baseline VH:CD ratio, site, and sex as covariates and treatment group as a fixed effect. |
| 0.0343 |
| LS Mean Difference |
| -41.24 |
| Standard Error of the Mean |
| 18.85 |
| 2-Sided |
| 95 |
| -79.28 |
| -3.2 |
| Superiority |
| Mixed-effect Model Repeat Measurement |
The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects. |
| 0.4228 |
| LS Mean Difference |
| 944.90 |
| Standard Error of the Mean |
| 1167.22 |
| 2-Sided |
| 95 |
| -1410.65 |
| 3300.44 |
| Superiority |
|
Analysis of Change From Baseline in Anti-DGP-IgA |
| Mixed-effect Model Repeat Measurement |
The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects. |
| 0.6569 |
| LS Mean Difference |
| -6.92 |
| Standard Error of the Mean |
| 15.46 |
| 2-Sided |
| 95 |
| -38.11 |
| 24.28 |
| Superiority |
| Analysis of Change From Baseline in Anti-DGP-IgG | Mixed-effect Model Repeat Measurement | The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects. | 0.6254 | LS Mean Difference | 13.17 | Standard Error of the Mean | 26.77 | 2-Sided | 95 | -40.86 | 67.20 | Superiority |
| Analysis of Change From Baseline in Anti-DGP IgG | Mixed-effect Model Repeat Measurement | The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects. | 0.8955 | LS Mean Difference | 2.86 | Standard Error of the Mean | 21.66 | 2-Sided | 95 | -40.84 | 46.57 | Superiority |
|
| Generalized Linear Mixed Model |
Generalized linear mixed model with treatment group, site, sex, time (week), and time point-by-treatment group interaction as fixed effects. |
| 0.7810 |
| Ratio of LS Means |
| 1.03 |
| Standard Error of the Mean |
| 0.13 |
| 2-Sided |
| 95 |
| 0.81 |
| 1.32 |
| Superiority |
| Title | Measurements |
|---|---|
|
| Mixed-effect Model Repeat Measurement |
The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects. |
| 0.8221 |
| LS Mean Difference |
| -2.62 |
| Standard Error of the Mean |
| 11.66 |
| 2-Sided |
| 95 |
| -25.51 |
| 20.27 |
| Superiority |
| Mixed-effect Model Repeat Measurement |
The model included baseline value, treatment group, site, sex, time point, and a time point-by-treatment group interaction term as fixed effects. |
| 0.4088 |
| LS Mean Difference |
| -1.64 |
| Standard Error of the Mean |
| 1.98 |
| 2-Sided |
| 95 |
| -5.53 |
| 2.25 |
| Superiority |