Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CAAA113A22101 | Other Identifier | Novartis |
Not provided
Not provided
Not provided
Low recruitment
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This was a monocentric, open label, Phase I-IIa study. Eligible patients who signed the ICF received two single intravenous (IV) bolus of the imaging agent 99mTc-rhAnnexin V-128. The first dose was administered on Day 1, and the second dose on Day 42 (±2 weeks).
All patients were to start a new disease modifying treatment for RA or AS on Day 2. This disease modifying treatment was at the discretion of the investigator and was not chosen by the sponsor.
Safety was monitored at every visit. Whole body scintigraphic imaging was performed at Day 1 and Day 42 after 99mTc-rhAnnexin V-128 dosing. Clinical disease assessments were performed at screening, Day 42 and Day 90 to assess response to RA or AS treatment. Blood was drawn to test for 99mTc-rhAnnexin V-128 immunogenicity at screening and on Days 30, 56 and 90. Patients participating in the pharmacokinetic (PK)/dosimetric sub-study had additional assessments in the 24 hours following the Day 1 dose of 99mTc-rhAnnexin V-128.
The study was terminated early after the inclusion of 16 of the 20 planned patients. The sponsor decided to terminate the study earlier than planned due to slow accrual. Novartis acquired Advanced Accelerator Applications SA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 99mTc-rhAnnexin V-128, i.v. | Experimental | Patients will receive 2 administrations of the 99mTc-rhAnnexin V-128 medical imaging agent: one at Day 1 and the other at Day 42. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 99mTc-rhAnnexin V-128 | Drug | 1 single intravenous bolus administration of 250 MBq, at Day 1 and at Day 42. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE) and Death | An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with the study medication. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease, temporally associated with the use of a study medication, whether or not causally related to the study medication. TEAEs are defined as all AEs reported after the first dose. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, life-threatening, results in persistent or significant disability/incapacity, results in congenital anomaly or birth defect, requires in-patient hospitalization or leads to prolongation of hospitalization. | From screening up to Day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve Extrapolated to Infinity (AUC) of 99mTc-rhAnnexin V-128 | AUC is defined as area under the curve extrapolated to infinity of 99mTc-rhAnnexin V-128. | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours) |
| Distribution Volume (Vz) of 99mTc-rhAnnexin V-128 |
Not provided
Inclusion Criteria:
or RA patients must have been previously treated with Bi-DMARD before initiation of the new Bi-DMARD treatment. The non-response of the previous Bi-DMARD treatment must be documented.
or Patients with AS with insufficiently controlled disease while under NSAID and indication for Bi-DMARD. These patients must be under NSAID for at least 3 months and under the same NSAID for at least 1 month prior to enrollment.
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| John Prior, MD, PhD | CHUV Lausanne | Principal Investigator |
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire Vaudois | Lausanne | Canton of Vaud | 1011 | Switzerland |
Not provided
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Of the 16 enrolled participants, 10 participants would take part in a PK/dosimetric sub-study, after providing written approval (only 5 participants were enrolled to the sub-study). Of the first 6 enrolled participants overall, at least 3 had to take part in the sub-study to optimise the PK time points for subsequent participants .
It was planned that 20 evaluable patients with either RA or AS (enrolled in a 1:1 ratio) would be included and would complete the assessments on Day 56, however recruitment was terminated after inclusion of 16 patients.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 99mTc-rhAnnexin V-128: Ankylosing Spondylitis | Participants with Ankylosing Spondylitis (AS) received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 Megabecquerel (MBq) through an intravenous (IV) catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42. |
| FG001 | 99mTc-rhAnnexin V-128: Rheumatoid Arthritis | Participants with Rheumatoid Arthritis (RA) received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety analysis set included participants who have received at least one dose of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 99mTc-rhAnnexin V-128: Ankylosing Spondylitis | Participants with AS received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42. |
| BG001 | 99mTc-rhAnnexin V-128: Rheumatoid Arthritis |
| 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAE) and Death | An adverse event (AE) is defined as any untoward medical occurrence in a patient and which does not necessarily have a causal relationship with the study medication. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease, temporally associated with the use of a study medication, whether or not causally related to the study medication. TEAEs are defined as all AEs reported after the first dose. An SAE is any untoward medical occurrence that at any dose: results in death, is life-threatening, life-threatening, results in persistent or significant disability/incapacity, results in congenital anomaly or birth defect, requires in-patient hospitalization or leads to prolongation of hospitalization. | Safety analysis set included all participants who have received at least one dose of study drug. | Posted | Count of Participants | Participants | From screening up to Day 90 |
|
From start of screening up to Day 90
Safety set included all eligible participants who were administered at least one treatment.
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 | 99mTc-rhAnnexin V-128: Ankylosing Spondylitis | Participants with AS received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Depression | Psychiatric disorders | MedDRA, Version 20.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA, Version 20.1 | Systematic Assessment |
The sponsor decided to terminate the study earlier than planned due to slow accrual (16 of the planned 20 patients).
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 | Novartis.email@novartis.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 | Dec 16, 2014 | Apr 8, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 26, 2018 | Apr 8, 2020 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013167 | Spondylitis, Ankylosing |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
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Vz is defined as the distribution volume of 99mTc-rhAnnexin V-128. |
| Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours) |
| Systemic Clearance (Cl) of 99mTc-rhAnnexin V-128 | Cl is defined as the systemic clearance of 99mTc-rhAnnexin V-128. | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours) |
| Elimination Half-life (t1/2) of 99mTc-rhAnnexin V-128 | t1/2 is defined as the elimination half-life of 99mTc-rhAnnexin V-128. | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours) |
| Serum Concentration of rhAnnexin V-128 Based on Enzyme-linked Immunosorbent Assay (ELISA) Analysis | Serum concentration of rhAnnexin V-128 based on ELISA analysis were to be evaluated and reported overtime. | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00 and 24.00 hours) |
| 99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) | Total radioactivity count per minute in whole blood samples were reported. | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50 to 2.00, 3.00 to 4.00 and 24.00 hours) |
| 99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) | Total radioactivity count per minute in serum samples were reported. | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50 to 2.00, 3.00 to 4.00, 6.00 and 24.00 hours) |
| 99mTc-rhAnnexin V-128 Urine Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) | Total radioactivity count per minute in urine samples were reported. | Day 1 (0 (Predose), 1.00, 4.00, 6.00 and 24.00 hours) |
| Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis | Urine samples (10 mL aliquots) were analysed as a function of time by SEC-HPLC technique at the local laboratory in order to gain information on the chemical status of 99mTc-rhAnnexin V-128 and on the presence of 99mTc-rhAnnexin V-128-related species. | Day 1 (0 (Predose), up to 1.00 hour, from 1.00 to 4.00 hours, from 4.00 to 6.00 hours, from 16.00 to 24.00 hours) |
Participants with RA received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42. |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG000 |
| 99mTc-rhAnnexin V-128: Ankylosing Spondylitis |
Participants with AS received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42. |
| OG001 | 99mTc-rhAnnexin V-128: Rheumatoid Arthritis | Participants with RA received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42. |
|
|
| Secondary | Area Under the Curve Extrapolated to Infinity (AUC) of 99mTc-rhAnnexin V-128 | AUC is defined as area under the curve extrapolated to infinity of 99mTc-rhAnnexin V-128. | PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Here 'n' (number analyzed) signifies participants who were evaluable for specified categories. | Posted | Mean | Standard Deviation | nanogram*hour per milliliter (ng.h/mL) | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours) |
|
|
|
| Secondary | Distribution Volume (Vz) of 99mTc-rhAnnexin V-128 | Vz is defined as the distribution volume of 99mTc-rhAnnexin V-128. | PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Here 'n' (number analyzed) signifies participants who were evaluable for specified categories. | Posted | Mean | Standard Deviation | Liters (L) | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours) |
|
|
|
| Secondary | Systemic Clearance (Cl) of 99mTc-rhAnnexin V-128 | Cl is defined as the systemic clearance of 99mTc-rhAnnexin V-128. | PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Here 'n' (number analyzed) signifies participants who were evaluable for specified categories. | Posted | Mean | Standard Deviation | Liter per hour (L/h) | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours) |
|
|
|
| Secondary | Elimination Half-life (t1/2) of 99mTc-rhAnnexin V-128 | t1/2 is defined as the elimination half-life of 99mTc-rhAnnexin V-128. | PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Here 'n' (number analyzed) signifies participants who were evaluable for specified categories. | Posted | Mean | Standard Deviation | hours | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 4.00 and 24.00 hours) |
|
|
|
| Secondary | Serum Concentration of rhAnnexin V-128 Based on Enzyme-linked Immunosorbent Assay (ELISA) Analysis | Serum concentration of rhAnnexin V-128 based on ELISA analysis were to be evaluated and reported overtime. | Pharmacokinetic (PK) population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Due to low concentration of the protein in serum PK parameters could not be derived. | Posted | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50, 2.00, 3.00, 4.00, 6.00 and 24.00 hours) |
|
|
| Secondary | 99mTc-rhAnnexin V-128 Blood Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) | Total radioactivity count per minute in whole blood samples were reported. | PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Here 'n' (number analyzed) signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | counts per minute (CPM) in 1 mL sample | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50 to 2.00, 3.00 to 4.00 and 24.00 hours) |
|
|
|
| Secondary | 99mTc-rhAnnexin V-128 Serum Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) | Total radioactivity count per minute in serum samples were reported. | PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Here 'n' (number analyzed) signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | counts per minute (CPM) in 1 mL sample | Day 1 (0 (Predose), 0.05, 0.10, 0.15, 0.30, 1.00, 1.50 to 2.00, 3.00 to 4.00, 6.00 and 24.00 hours) |
|
|
|
| Secondary | 99mTc-rhAnnexin V-128 Urine Cpm Decay Corrected Data (Counts Per Minute in 1 mL Sample) | Total radioactivity count per minute in urine samples were reported. | PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). Here 'n' (number analyzed) signifies participants who were evaluable at specified timepoints. | Posted | Mean | Standard Deviation | counts per minute (CPM) in 1 mL sample | Day 1 (0 (Predose), 1.00, 4.00, 6.00 and 24.00 hours) |
|
|
|
| Secondary | Number of Annexin Related Species as Assessed Size-Exclusion HPLC- High-Performance Liquid Chromatography (SEC-HPLC) Analysis | Urine samples (10 mL aliquots) were analysed as a function of time by SEC-HPLC technique at the local laboratory in order to gain information on the chemical status of 99mTc-rhAnnexin V-128 and on the presence of 99mTc-rhAnnexin V-128-related species. | PK population included all participants who participated in the PK/dosimetry sub-study which included participants regardless of their diagnosis (RA or AS). | Posted | Count of Participants | Participants | Day 1 (0 (Predose), up to 1.00 hour, from 1.00 to 4.00 hours, from 4.00 to 6.00 hours, from 16.00 to 24.00 hours) |
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| 3 |
| 5 |
| EG001 | 99mTc-rhAnnexin V-128: Rheumatoid Arthritis | Participants with RA received received a single bolus injection of 99mTc-rhAnnexin V-128 at a dose of 250 MBq through an IV catheter in an antecubital vein, followed by a saline flush on Day 1 and on Day 42. | 0 | 11 | 1 | 11 | 11 | 11 |
| Cyanosis | Cardiac disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Faeces discoloured | Gastrointestinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Chills | General disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Cytokine release syndrome | Immune system disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Infection | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA, Version 20.1 | Systematic Assessment |
|
| Procedural dizziness | Injury, poisoning and procedural complications | MedDRA, Version 20.1 | Systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA, Version 20.1 | Systematic Assessment |
|
| Blood urine present | Investigations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Weight increased | Investigations | MedDRA, Version 20.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Cognitive disorder | Nervous system disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Dementia | Nervous system disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Paresis | Nervous system disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Urinary tract pain | Renal and urinary disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Urine odour abnormal | Renal and urinary disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA, Version 20.1 | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000089183 | Axial Spondyloarthritis |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D000844 | Ankylosis |
|
|
|
|
|
| 10 min |
|
|
| 15 min |
|
|
| 30 min |
|
|
| 1h |
|
|
| 1.5h to 2.0h |
|
|
| 3.0h to 4.0h |
|
|
| 24h |
|
|
|
| 10 min |
|
|
| 15 min |
|
|
| 30 min |
|
|
| 1h |
|
|
| 1.5h to 2.0h |
|
|
| 3.0h to 4.0h |
|
|
| 6h |
|
|
| 24h |
|
|
|
| 4 hours |
|
|
| 16 hours |
|
|
| 24 hours |
|
|
| Up to 1 hour-HPLC Performed?=Yes |
|
|
| From 1 to 4 hours-HPLC Performed?=Yes |
|
|
| From 4 to 6 hours-HPLC Performed?=Yes |
|
|
| From 16 to 24 hours-HPLC Performed?=Yes |
|
|
| From 16 to 24 hours-HPLC Performed?=No |
|
|