Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00669942
Collaborator
(none)
104
24
12
35
4.3
0.1
Study Details
Study Description
Brief Summary
Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
104 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Basic Science
Official Title:
A Randomized, Double Blind, Placebo-controlled, Dose Escalation Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients With Pharmacodynamics Assessed in an Expanded Cohort at the Maximum Tolerated Dose
Study Start Date
:
Dec 1, 2005
Actual Primary Completion Date
:
Nov 1, 2008
Actual Study Completion Date
:
Nov 1, 2008
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1 - AIN457A 0.3 mg/kg AIN457A 0.3 mg/kg was administered intravenously as a single dose. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Experimental: Part 1 - AIN457A 1.0 mg/kg AIN457A 1.0 mg/kg was administered intravenously as a single dose. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Experimental: Part 1 - AIN457A 3.0 mg/kg AIN457A 3.0 mg/kg was administered intravenously as a single dose. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Experimental: Part 1 - AIN457A 10 mg/kg AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Placebo Comparator: Part 1 - Placebo Placebo to AIN457A was administered intravenously as a single dose. |
Drug: Placebo
Placebo to AIN457
|
| Experimental: Parts 2 and 3 - AIN457A 1.0 mg/kg AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Experimental: Parts 2 and 3 - AIN457A 3.0 mg/kg AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Experimental: Parts 2 and 3 - AIN457A 10 mg/kg AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Placebo Comparator: Parts 2 and 3 - Placebo Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
Drug: Placebo
Placebo to AIN457
|
| Experimental: Part 1 - Healthy Volunteers - AIN457A 3 mg/kg AIN457A 3.0 mg/kg was administered intravenously as a single dose. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Experimental: Part 1 - Healthy Volunteers - AIN457A 10 mg/kg AIN457A 10 mg/kg was administered intravenously as a single dose. |
Biological: AIN457
AIN457A is a fully human recombinant IgG1 antibody that targets and neutralizes IL-17A.
|
| Placebo Comparator: Part 1 - Healthy Volunteers - Placebo Placebo to AIN457A was administered intravenously as a single dose. |
Drug: Placebo
Placebo to AIN457
|
Outcome Measures
Primary Outcome Measures
- Percentage of Parts 2 and 3 Participants Who Achieved American College of Rheumatology Response of 20 (ACR20) [Day 43]
Clinical response to treatment was assessed according to ACR20 criteria. A participant was defined as an ACR20 responder if the following 3 conditions were met: 1) ≥20% improvement in the number of tender joints, 2) ≥20% improvement in the number of swollen joint and 3) ≥20% improvement in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant.
- Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 29, 36, 43, 57, 71, 85, 99 and 113.
- PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- Pharmacokinetics PK of AIN457: Tmax in Parts 2 and 3 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- Pharmacokinetics PK of AIN457: Cmax in Parts 2 and 3 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- Pharmacokinetics PK of AIN457: AUClast and AUCinf in Parts 2 and 3 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- Pharmacokinetics PK of AIN457: Vz in Parts 2 and 3 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- Pharmacokinetics PK of AIN457: CL in Parts 2 and 3 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
- Pharmacokinetics PK of AIN457: T1/2 in Parts 2 and 3 Participants [Day 113]
Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion.
Secondary Outcome Measures
- Percentage of Parts 2 and 3 Participants Who Achieved ACR50 and ACR70 [Day 43]
Clinical response to treatment was assessed according to ACR50 and ACR70 criteria. A participant was defined as an ACR50 or ACR70 responder if the following 3 conditions were met: 1) improvement of ≥50% or ≥ 70%, respectively, in the number of tender joints, 2) improvement of ≥50% or ≥ 70%, respectively, in the number of swollen joints and 3) improvement of ≥50% or ≥ 70%, respectively, in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant
- Disease Activity Score (DAS28) of Parts 2 and 3 Participants [Day 43]
The DAS28 is a composite score based on tender and swollen joint counts, C reactive protein (CRP) concentrations, and the participant's global disease activity based on a visual analogue scale (VAS). The tender joint count (based on 28 joints) was calculated by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. The information on various types of tenderness was then collapsed into a single tender versus non-tender dichotomy, and the number of joints that were classified as tender was recorded. The swollen joint count was calculated in the same manner. For CRP concentrations, blood samples were collected and sent to a central laboratory for assessment. For the VAS assessment, the participant used a 100 mm horizontal VAS to assess the severity of his or her arthritis where 0 = none and 100 = most severe. DAS28 scores range from <2.6 (disease remission) to >5.1 (high disease activity).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Male and female patients with active rheumatoid arthritis in combination with a stable dose of methotrexate aged 18-75 years may participate in this trial.
-
Post menopausal or surgically sterile female patients are allowed. Women of child-bearing potential may participate if they are on a stable dose of methotrexate and if they are practicing effective contraception for at least 6 months prior to screening, willing to use 2 forms of contraception, including at least 1 barrier method during the study and for at least 2 months following the completion/discontinuation of the study.
-
Patients must have a diagnosis of active rheumatoid arthritis of stages I, II or III (ACR 1987 revised classification for criteria for RA). Disease duration of at least 6 months prior to randomization is essential;
Exclusion Criteria:
-
Current treatment with anti-TNF-α or anti IL-1 therapy (or other biological therapy).
-
Patients with congestive heart failure or poorly controlled diabetes mellitus (HbA1c value ≥10%).
-
Presence of any major chronic inflammatory autoimmune diseases like psoriasis, psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease or SLE that can mimic rheumatoid arthritis diagnosis or that can interfere with efficacy evaluation in the study.
-
History of renal trauma, glomerulonephritis or patient with one kidney.
-
Pregnant or breastfeeding women will be excluded.
-
A positive tuberculin skin test.
Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Anniston | Alabama | United States | 36207-5710 |
| 2 | Novartis Investigative Site | Tucson | Arizona | United States | 85724 |
| 3 | Novartis Investigative Site | Largo | Florida | United States | 33773 |
| 4 | Novartis Investigative Site | Ocala | Florida | United States | 34471 |
| 5 | Novartis Investigative Site | Palm Harbor | Florida | United States | 34684 |
| 6 | Novartis Investigative Site | Port Orange | Florida | United States | 32127 |
| 7 | Novartis Investigative Site | Madisonville | Kentucky | United States | 42431 |
| 8 | Novartis Investigative Site | St. Louis | Missouri | United States | 63110 |
| 9 | Novartis Investigative Site | Omaha | Nebraska | United States | 68131-2197 |
| 10 | Novartis Investigative Site | Oklahoma City | Oklahoma | United States | 73103 |
| 11 | Novartis Investigative Site | Bend | Oregon | United States | 97701 |
| 12 | Novartis Investigative Site | Duncansville | Pennsylvania | United States | 16635 |
| 13 | Novartis Investigative Site | Bruxelles | Belgium | 1200 | |
| 14 | Novartis Investigative Site | Merksem | Belgium | 2170 | |
| 15 | Novartis Investigative Site | Bad Nauheim | Germany | 61231 | |
| 16 | Novartis Investigative Site | Erlangen | Germany | 91054 | |
| 17 | Novartis Investigative Site | Muenchen | Germany | 80336 | |
| 18 | Novartis Investigative Site | Amsterdam | Netherlands | 1105 AZ | |
| 19 | Novartis Investigative Site | Nijmegen | Netherlands | 6525 GA | |
| 20 | Novartis Investigative Site | Singapore | Singapore | 119074 | |
| 21 | Novartis Investigative Site | Singapore | Singapore | 529889 | |
| 22 | Novartis Investigative Site | La Coruna | Galicia | Spain | 15006 |
| 23 | Novartis Investigative Site | Santiago de Compostela | Galicia | Spain | 15706 |
| 24 | Novartis Investigative Site | Guadalajara | Spain | 19002 |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
- Principal Investigator: Novartis, Novartis investigator site
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00669942
Other Study ID Numbers:
- CAIN457A2101
First Posted:
May 1, 2008
Last Update Posted:
Mar 30, 2015
Last Verified:
Mar 1, 2015
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | Part 1: single dose escalation - sequential cohorts of patients and healthy volunteers received AIN457A or placebo. Part 2: multiple dose escalation - sequential cohorts of patients received 2 doses of AIN457A or placebo. Part 3: patients received 2 doses of AIN457 10 mg/kg (or the maximum tolerated dose) or placebo. |
|---|---|
| Pre-assignment Detail | In parts 1 and 2, participants were randomized 3:1 to receive AIN457A or placebo. In part 3, participants were randomized 1:1 to receive AIN457A or placebo. |
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg | Part 1 - Placebo | Parts 2 and 3 - AIN457A 1.0 mg/kg | Parts 2 and 3 - AIN457A 3.0 mg/kg | Parts 2 and 3 - AIN457A 10 mg/kg | Parts 2 and 3 - Placebo | Part 1 - Healthy Volunteers - AIN457A 3 mg/kg | Part 1 - Healthy Volunteers - AIN457A 10 mg/kg | Part 1 - Healthy Volunteers - Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. | Placebo to AIN457A was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10 mg/kg was administered intravenously as a single dose. | Placebo to AIN457A was administered intravenously as a single dose. |
| Period Title: Part 1 | ||||||||||||
| STARTED | 6 | 6 | 6 | 6 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| COMPLETED | 6 | 6 | 6 | 6 | 8 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Period Title: Part 1 | ||||||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 6 | 6 | 26 | 26 | 0 | 0 | 0 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 4 | 6 | 24 | 23 | 0 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 2 | 3 | 0 | 0 | 0 |
| Period Title: Part 1 | ||||||||||||
| STARTED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 3 | 2 |
| COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 2 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
Baseline Characteristics
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg | Part 1 - Placebo | Parts 2 and 3 - AIN457A 1.0 mg/kg | Parts 2 and 3 - AIN457A 3.0 mg/kg | Parts 2 and 3 - AIN457A 10 mg/kg | Parts 2 and 3 - Placebo | Part 1 - Healthy Volunteers - AIN457A 3 mg/kg | Part 1 - Healthy Volunteers - AIN457A 10 mg/kg | Part 1 - Healthy Volunteers - Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. | Placebo to AIN457A was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10 mg/kg was administered intravenously as a single dose. | Placebo to AIN457A was administered intravenously as a single dose. | Total of all reporting groups |
| Overall Participants | 6 | 6 | 6 | 6 | 8 | 6 | 6 | 26 | 26 | 3 | 3 | 2 | 104 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||||||
| Mean (Standard Deviation) [Years] |
57.6
(8.04)
|
58.8
(13.61)
|
51.2
(9.50)
|
63.2
(9.45)
|
57.8
(3.41)
|
60.8
(8.66)
|
56.0
(12.00)
|
49.9
(8.53)
|
49.8
(15.19)
|
26.7
(10.02)
|
22.3
(2.31)
|
42.5
(10.61)
|
46.07
(10.83)
|
| Sex: Female, Male (Count of Participants) | |||||||||||||
| Female |
5
83.3%
|
5
83.3%
|
5
83.3%
|
5
83.3%
|
7
87.5%
|
5
83.3%
|
3
50%
|
19
73.1%
|
20
76.9%
|
0
0%
|
0
0%
|
1
50%
|
75
72.1%
|
| Male |
1
16.7%
|
1
16.7%
|
1
16.7%
|
1
16.7%
|
1
12.5%
|
1
16.7%
|
3
50%
|
7
26.9%
|
6
23.1%
|
3
100%
|
3
100%
|
1
50%
|
29
27.9%
|
Outcome Measures
| Title | Percentage of Parts 2 and 3 Participants Who Achieved American College of Rheumatology Response of 20 (ACR20) |
|---|---|
| Description | Clinical response to treatment was assessed according to ACR20 criteria. A participant was defined as an ACR20 responder if the following 3 conditions were met: 1) ≥20% improvement in the number of tender joints, 2) ≥20% improvement in the number of swollen joint and 3) ≥20% improvement in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant. |
| Time Frame | Day 43 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 10 mg/kg | Parts 2 and 3 - Placebo |
|---|---|---|
| Arm/Group Description | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 26 | 26 |
| Number [percentage of participants] |
46
766.7%
|
27
450%
|
| Title | Pharmacokinetics (PK) of AIN457: Time to Reach the Maximum Concentration After Drug Administration (Tmax) in Part 1 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 29, 36, 43, 57, 71, 85, 99 and 113. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile. |
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
| Measure Participants | 5 | 6 | 6 | 6 |
| Median (Full Range) [day] |
0.09028
|
0.08472
|
0.1253
|
0.1260
|
| Title | PK of AIN457: Observed Maximum Serum Concentration Following Drug Administration (Cmax) in Part 1 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile. |
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
| Measure Participants | 5 | 6 | 6 | 6 |
| Mean (Standard Deviation) [ug/mL] |
8.772
(1.8020)
|
35.22
(18.755)
|
70.95
(9.9472)
|
211.8
(36.837)
|
| Title | PK of AIN457: Area Under the Serum Concentration-time Cure From Time Zero to the Time of Last Quantifiable Concentration (AUClast), Area Under the Serum Concentration-time Curve From Time Zero to (AUCinf) in Part 1 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile. |
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
| Measure Participants | 5 | 6 | 6 | 6 |
| AUCinf |
141.3
(48.781)
|
430.7
(48.281)
|
1148
(330.89)
|
4080
(768.87)
|
| AUClast |
132.7
(42.824)
|
415.6
(42.793)
|
1097
(291.59)
|
3936
(697.65)
|
| Title | PK of AIN457: Volume of Distribution During the Terminal Phase Following Intravenous Elimination (Vz) in Part 1 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile. |
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
| Measure Participants | 5 | 6 | 6 | 6 |
| Mean (Standard Deviation) [Liters] |
7.043
(2.0197)
|
6.756
(2.2186)
|
6.506
(0.83822)
|
6.699
(0.83967)
|
| Title | PK of AIN457: Systemic Clearance From Serum Following Intravenous Administration (CL) in Part 1 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. One participant in the 0.3 mg/kg arm was not analyzed due to an atypical PK profile. |
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
| Measure Participants | 5 | 6 | 6 | 6 |
| Mean (Standard Deviation) [Liters/day] |
0.2249
(0.11196)
|
0.2110
(0.064415)
|
0.2077
(0.080880)
|
0.1999
(0.049375)
|
| Title | PK of AIN457: Terminal Elimination Half-life (T1/2) in Part 1 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Part 1 participants who received AIN457A at 0.3 mg/kg, 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. |
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg |
|---|---|---|---|---|
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. |
| Measure Participants | 6 | 6 | 6 | 6 |
| Mean (Standard Deviation) [day] |
23.21
(6.8285)
|
22.27
(2.8478)
|
23.47
(5.7952)
|
23.94
(4.2566)
|
| Title | Pharmacokinetics PK of AIN457: Tmax in Parts 2 and 3 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 1.0 mg/kg | Parts 2 and 3 - AIN457A 3.0 mg/kg | Parts 2 and 3 - AIN457A 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 6 | 6 | 26 |
| Median (Full Range) [day] |
21.08
|
21.08
|
21.09
|
| Title | Pharmacokinetics PK of AIN457: Cmax in Parts 2 and 3 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 1.0 mg/kg | Parts 2 and 3 - AIN457A 3.0 mg/kg | Parts 2 and 3 - AIN457A 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 6 | 6 | 26 |
| Mean (Standard Error) [ug/mL] |
23.54
(3.1588)
|
97.78
(15.543)
|
322.2
(96.719)
|
| Title | Pharmacokinetics PK of AIN457: AUClast and AUCinf in Parts 2 and 3 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 1.0 mg/kg | Parts 2 and 3 - AIN457A 3.0 mg/kg | Parts 2 and 3 - AIN457A 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 6 | 6 | 26 |
| AUCinf |
808.6
(251.01)
|
2843
(481.49)
|
8371
(2505.8)
|
| AUClast |
746.4
(209.20)
|
2704
(467.60)
|
7815
(2102.0)
|
| Title | Pharmacokinetics PK of AIN457: Vz in Parts 2 and 3 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 1.0 mg/kg | Parts 2 and 3 - AIN457A 3.0 mg/kg | Parts 2 and 3 - AIN457A 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 6 | 6 | 26 |
| Mean (Standard Deviation) [Liter] |
6.514
(1.1542)
|
6.062
(1.0189)
|
6.382
(1.1336)
|
| Title | Pharmacokinetics PK of AIN457: CL in Parts 2 and 3 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 1.0 mg/kg | Parts 2 and 3 - AIN457A 3.0 mg/kg | Parts 2 and 3 - AIN457A 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 6 | 6 | 26 |
| Mean (Standard Deviation) [Liters/day] |
0.1834
(0.042822)
|
0.1775
(0.034075)
|
0.1994
(0.063454)
|
| Title | Pharmacokinetics PK of AIN457: T1/2 in Parts 2 and 3 Participants |
|---|---|
| Description | Serum samples were collected pre-dose and 0.5, 2, 4, 7, 12 and 24 hours post infusion on day 1, and on days 2, 5, 8, 15, 22, 23, 26, 29, 36, 43, 57, 71, 85, 99 and 113. On day 22, samples were collected pre-dose and 0.5, 1, 2, 4, 7 and 24 hours post infusion. |
| Time Frame | Day 113 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Parts 2 and 3 participants who received AIN457A at 1 mg/kg, 3 mg/kg or 10 mg/kg were included in this analysis. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 1.0 mg/kg | Parts 2 and 3 - AIN457A 3.0 mg/kg | Parts 2 and 3 - AIN457A 10 mg/kg |
|---|---|---|---|
| Arm/Group Description | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 6 | 6 | 26 |
| Mean (Standard Deviation) [Day] |
25.60
(6.3100)
|
23.89
(3.2335)
|
23.68
(6.3048)
|
| Title | Percentage of Parts 2 and 3 Participants Who Achieved ACR50 and ACR70 |
|---|---|
| Description | Clinical response to treatment was assessed according to ACR50 and ACR70 criteria. A participant was defined as an ACR50 or ACR70 responder if the following 3 conditions were met: 1) improvement of ≥50% or ≥ 70%, respectively, in the number of tender joints, 2) improvement of ≥50% or ≥ 70%, respectively, in the number of swollen joints and 3) improvement of ≥50% or ≥ 70%, respectively, in three of the following five domains: patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire (HAQ) and acute phase reactant |
| Time Frame | Day 43 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 10 mg/kg | Parts 2 and 3 - Placebo |
|---|---|---|
| Arm/Group Description | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 26 | 26 |
| ACR50 |
27
450%
|
15
250%
|
| ACR70 |
8
133.3%
|
8
133.3%
|
| Title | Disease Activity Score (DAS28) of Parts 2 and 3 Participants |
|---|---|
| Description | The DAS28 is a composite score based on tender and swollen joint counts, C reactive protein (CRP) concentrations, and the participant's global disease activity based on a visual analogue scale (VAS). The tender joint count (based on 28 joints) was calculated by scoring several different aspects of tenderness as assessed by pressure and joint manipulation on physical examination. The information on various types of tenderness was then collapsed into a single tender versus non-tender dichotomy, and the number of joints that were classified as tender was recorded. The swollen joint count was calculated in the same manner. For CRP concentrations, blood samples were collected and sent to a central laboratory for assessment. For the VAS assessment, the participant used a 100 mm horizontal VAS to assess the severity of his or her arthritis where 0 = none and 100 = most severe. DAS28 scores range from <2.6 (disease remission) to >5.1 (high disease activity). |
| Time Frame | Day 43 |
Outcome Measure Data
| Analysis Population Description |
|---|
| The analysis was performed on the 10 mg and placebo treatment arms of the parts 2 and 3 participants. |
| Arm/Group Title | Parts 2 and 3 - AIN457A 10 mg/kg | Parts 2 and 3 - Placebo |
|---|---|---|
| Arm/Group Description | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. |
| Measure Participants | 25 | 23 |
| Mean (Standard Error) [scores on a scale] |
4.306
(1.4787)
|
4.598
(1.2618)
|
Adverse Events
| Time Frame | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||||||||||
| Arm/Group Title | Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg | Part 1 - Placebo | Parts 2 and 3 - AIN457 1.0 mg/kg | Parts 2 and 3 - AIN457 3.0 mg/kg | Parts 2 and 3 - AIN457 10 mg/kg | Parts 2 and 3 - Placebo | Part 1 - Healthy Volunteers - AIN457A 3 mg/kg | Part 1 - Healthy Volunteers - Placebo | Part 1 - Healthy Volunteers - AIN457A 10 mg/kg | ||||||||||||
| Arm/Group Description | AIN457A 0.3 mg/kg was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as a single dose. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | AIN457A 10.0 mg/kg was administered intravenously as a single dose. | Placebo to AIN457A was administered intravenously as a single dose. | AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 10.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | Placebo to AIN457A was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22. | AIN457A 3.0 mg/kg was administered intravenously as a single dose. | Placebo to AIN457A was administered intravenously as a single dose. | AIN457A 10 mg/kg was administered intravenously as a single dose. | ||||||||||||
All Cause Mortality |
||||||||||||||||||||||||
| Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg | Part 1 - Placebo | Parts 2 and 3 - AIN457 1.0 mg/kg | Parts 2 and 3 - AIN457 3.0 mg/kg | Parts 2 and 3 - AIN457 10 mg/kg | Parts 2 and 3 - Placebo | Part 1 - Healthy Volunteers - AIN457A 3 mg/kg | Part 1 - Healthy Volunteers - Placebo | Part 1 - Healthy Volunteers - AIN457A 10 mg/kg | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||||||
Serious Adverse Events |
||||||||||||||||||||||||
| Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg | Part 1 - Placebo | Parts 2 and 3 - AIN457 1.0 mg/kg | Parts 2 and 3 - AIN457 3.0 mg/kg | Parts 2 and 3 - AIN457 10 mg/kg | Parts 2 and 3 - Placebo | Part 1 - Healthy Volunteers - AIN457A 3 mg/kg | Part 1 - Healthy Volunteers - Placebo | Part 1 - Healthy Volunteers - AIN457A 10 mg/kg | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/26 (0%) | 2/26 (7.7%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||
| Brachial plexopathy | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Headache | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Reproductive system and breast disorders | ||||||||||||||||||||||||
| Endometrial hyperplasia | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
| Chronic obstructive pulmonary disease | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Interstitial lung disease | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||||||||||
| Part 1 - AIN457A 0.3 mg/kg | Part 1 - AIN457A 1.0 mg/kg | Part 1 - AIN457A 3.0 mg/kg | Part 1 - AIN457A 10 mg/kg | Part 1 - Placebo | Parts 2 and 3 - AIN457 1.0 mg/kg | Parts 2 and 3 - AIN457 3.0 mg/kg | Parts 2 and 3 - AIN457 10 mg/kg | Parts 2 and 3 - Placebo | Part 1 - Healthy Volunteers - AIN457A 3 mg/kg | Part 1 - Healthy Volunteers - Placebo | Part 1 - Healthy Volunteers - AIN457A 10 mg/kg | |||||||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/6 (50%) | 2/6 (33.3%) | 5/6 (83.3%) | 2/6 (33.3%) | 4/8 (50%) | 5/6 (83.3%) | 4/6 (66.7%) | 19/26 (73.1%) | 13/26 (50%) | 1/3 (33.3%) | 1/2 (50%) | 0/3 (0%) | ||||||||||||
| Blood and lymphatic system disorders | ||||||||||||||||||||||||
| Leukopenia | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/26 (3.8%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Cardiac disorders | ||||||||||||||||||||||||
| Angina pectoris | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Atrioventricular block first degree | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Ear and labyrinth disorders | ||||||||||||||||||||||||
| Ear pain | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Gastrointestinal disorders | ||||||||||||||||||||||||
| Abdominal pain upper | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Diarrhoea | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/8 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 1/26 (3.8%) | 2/26 (7.7%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Dyspepsia | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Haemorrhoids | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Nausea | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 3/26 (11.5%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Vomiting | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 1/26 (3.8%) | 3/26 (11.5%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| General disorders | ||||||||||||||||||||||||
| Asthenia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 2/26 (7.7%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Fatigue | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 2/6 (33.3%) | 0/6 (0%) | 2/26 (7.7%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Oedema peripheral | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Pain | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Pyrexia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/26 (3.8%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Infections and infestations | ||||||||||||||||||||||||
| Bronchitis | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/26 (3.8%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Fungal infection | 0/6 (0%) | 0/6 (0%) | 2/6 (33.3%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Influenza | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/26 (3.8%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Nasopharyngitis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 2/26 (7.7%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Paronychia | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Sinusitis | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Upper respiratory tract infection | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 2/26 (7.7%) | 2/26 (7.7%) | 0/3 (0%) | 1/2 (50%) | 0/3 (0%) | ||||||||||||
| Urinary tract infection | 2/6 (33.3%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 2/26 (7.7%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||||||||||
| Contusion | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/26 (3.8%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Excoriation | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 1/2 (50%) | 0/3 (0%) | ||||||||||||
| Fall | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 1/26 (3.8%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Foot fracture | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Ligament rupture | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 1/3 (33.3%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Limb injury | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Thermal burn | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Traumatic haematoma | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||||||||||
| Arthralgia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/8 (12.5%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Back pain | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 3/26 (11.5%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Flank pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Joint stiffness | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Lumbar spinal stenosis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Muscle spasms | 1/6 (16.7%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 2/26 (7.7%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Musculoskeletal pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Musculoskeletal stiffness | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Myalgia | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/26 (3.8%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Pain in extremity | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Rheumatoid arthritis | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 1/6 (16.7%) | 3/26 (11.5%) | 2/26 (7.7%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Nervous system disorders | ||||||||||||||||||||||||
| Carpal tunnel syndrome | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Dizziness | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 3/26 (11.5%) | 3/26 (11.5%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Dysgeusia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Headache | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/26 (3.8%) | 2/26 (7.7%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Tremor | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Psychiatric disorders | ||||||||||||||||||||||||
| Anxiety | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Insomnia | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Sleep disorder | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||||||||||
| Cough | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 2/26 (7.7%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Oropharyngeal pain | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 2/26 (7.7%) | 1/26 (3.8%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Postnasal drip | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||||||||||
| Ecchymosis | 1/6 (16.7%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Eczema | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 1/26 (3.8%) | 2/26 (7.7%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Vascular disorders | ||||||||||||||||||||||||
| Haematoma | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Hypertension | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 2/26 (7.7%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
| Hypotension | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) | 0/8 (0%) | 0/6 (0%) | 0/6 (0%) | 0/26 (0%) | 0/26 (0%) | 0/3 (0%) | 0/2 (0%) | 0/3 (0%) | ||||||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00669942
Other Study ID Numbers:
- CAIN457A2101
First Posted:
May 1, 2008
Last Update Posted:
Mar 30, 2015
Last Verified:
Mar 1, 2015