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MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01643850
Recruitment Status : Completed
First Posted : July 18, 2012
Results First Posted : February 27, 2020
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE March 8, 2012
First Posted Date  ICMJE July 18, 2012
Results First Submitted Date  ICMJE June 20, 2019
Results First Posted Date  ICMJE February 27, 2020
Last Update Posted Date January 5, 2021
Actual Study Start Date  ICMJE April 23, 2012
Actual Primary Completion Date December 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
  • Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size [ Time Frame: Week 4 ]
    To assess the efficacy of a single i.v. dose of MCS110 in changing the size of PVNS tumors (as compared to baseline) compared to placebo over 4 weeks evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
  • Percent Change in Pigmented Villonodular Synovitis (PVNS) Tumor Size [ Time Frame: Week 4 ]
    To assess the efficacy of a single i.v. dose of MCS110 in percent change of the PVNS tumor volume at week 4 as compared to baseline and compared to placebo evaluated by volume of PVNS tumors by 3-dimensional MRI. This analysis includes all data from patients who received at least a single dose of MCS110 (3, 5 or 10 mg/kg) or placebo and assesses the tumor volume changes at week 4 as compared to baseline. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
  • Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size [ Time Frame: Up to 8 weeks post last dose ]
    Assessment of maximum efficacy (multiple i.v.monthly doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 & 10 mg/kg or 5 & 10 mg/kg in changing PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Analysis included data starting from 1st dose of MCS110 in all treatment groups of Parts B and C. Part B patients who received placebo as 1st dose, measurement prior to receiving first dose of MCS110, was used as baseline and assessment time-points were adjusted accordingly. For Part C, participants starting treatment with low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and tumor volume reduction was ≤ 45%. Analysis includes data from patients who received at least 2 doses. The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg]
  • Percentage Change in Pigmented Villonodular Synovitis (PVNS) or Giant Cell Tumor of the Tendon Sheath (GCTTS) Tumor Size [ Time Frame: Up to 8 weeks post last dose ]
    To assess the maximum efficacy of multiple monthly i.v. doses (2 to 6) of 3, 5 or 10 mg/kg MCS110 or 3 and 10 mg/kg or 5 and 10 mg/kg by percent change in the PVNS tumor volume (as compared to baseline) up to 8 weeks post last dose evaluated by MRI. Subjects starting treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from all participants who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
  • Number of Participants With Adverse Events [ Time Frame: Approximately 2 years ]
    Overall incidence of Adverse Events
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
  • Change in pigmented villonodular synovitis (PVNS) tumor size [ Time Frame: week 4 ]
    A phase II randomized, double-blind, placebo controlled study to assess safety, tolerability and effect on tumor size of MCS110 in patients with pigmented villonodular synovitis (PVNS)
  • Number of Participants With Adverse Events [ Time Frame: week 4 ]
    adverse events assessment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 13, 2020)
  • Pharmacokinetics of MCS110 Area Under the Serum Concentration-time Curve (AUC) [ Time Frame: Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) ]
    Pharmacokinetic for a single dose of MCS110 for serum concentration -time curve (AUC).
  • Pharmacokinetics of MCS110 Maximum Concentration (Cmax) [ Time Frame: Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) ]
    Pharmacokinetic characterization of a single dose of MCS110 for maximum serum concentration (Cmax)
  • Pharmacokinetics of MCS110 Total Maximum Concentration (Tmax) [ Time Frame: Day 1 (0 - 5 hr), Day 29, Day 85, Day 112, PART B (Day 1: (0 -5 hr), (Day 85: 0 - 5 hr) PART C (Day 1: 0 -5 hr), (Day 85: 0-5 hr) ]
    Pharmacokinetic characterization of a single dose of MCS110 for time to maximum concentration (Tmax)
  • Change in Macrophage-colony Stimulating Factor (M-CSF) Plasma Concentrations Over Time [ Time Frame: Baseline, Day 1, Day 85, Day 169 ]
    Pharmacokinetic characterization of a single dose of MCS110 for evaluation of macrophage-colony stimulating factor (M-CSF) plasma concentrations over time
  • Change in Serum C-terminal Type 1 Collagen Peptide Concentrations (CTX-I). [ Time Frame: Baseline, Week 4, Week 24, Week 104 ]
    Pharmacodynamic characterization of a single dose of MCS110 by measuring C-terminal telopeptide of Type 1 Collagen peptide (CTX-I), a biomarker of bone resorption. Data measured in participants from three arms: participants from Part A, B and C who received a single dose of 10 mg/kg and had assessment at week 4 (Part ABC4); participants from Part A and B who received placebo ; and participants from Part B and C who received multiple monthly doses of MCS110 (10 mg/kg.) Serum CTX-I data were generated in Part A and Part B. In Part C, samples were collected for serum bone CTX-I analysis. The analysis was not performed, as enough information on compound mode of action was obtained using creatine kinase (CK) and monocytes (hematology) data. Only data from 10mg/kg (single and multiple doses) are available.
  • Number of Participants With Negative Anti-MCS110 Antibody [ Time Frame: Baseline, throughout the study up to Day 505 ]
    To assess the immunogenicity of MCS110 in serum anti-MCS110 antibody concentrations
  • Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion [ Time Frame: Week 4 ]
    To assess the clinical response of joint range of motion following a single i.v. dose of MCS110 or placebo as compared to baseline 4 weeks post-dose evaluated in participants, who had a knee tumor, which was the majority of participants (75%). The analysis includes all data from patients 4 weeks after receiving the first dose of MCS110 (3, 5 or 10 mg/kg) or placebo. As all parts (Part A, B and C) of the study are assessed after a single dose at week 4 the data set is called "ABC4".
  • Assessment of Change From Baseline in Joint Range of Motion for Knee Extension and Flexion [ Time Frame: Week 24/28, Week 104 ]
    To assess the clinical response of joint range of motion following multiple dose treatment with MCS110 3, 5, or 10 mg/kg evaluated in participants with knee tumor, which was the majority of participants (75%). The data presented are changes from baseline in degree. Participants, who started treatment with a low dose of MCS110 of 3 or 5 mg/kg could switch to 10 mg/kg after 3 monthly doses, if MCS110 was well tolerated and the tumor volume reduction was ≤ 45%. This analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
  • Change From Baseline in Joint Pain Using a Visual Analog Scale (VAS) [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 28, Week 40, Week 48, Week 104 ]
    Measurement of the participant's pain with a 100 mm visual analog scale (VAS) following treatment with MCS110 3, 5, or 10 mg/kg evaluated. Data presented are changes from baseline in degree. Participants were asked to place a line perpendicular to the VAS line at the point that represented her/his pain intensity. Using a ruler, the score was determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the participants mark, providing a score from 0-100. Analysis includes data from participants with knee tumor who received at least 2 doses of MCS110 and thus includes only patients from Part B and C of the study, thus the data set is called "Part BC". The following five groups were assessed: Subjects receiving only 3 mg/kg, only 5 mg/kg or 10 mg/kg and those who switched after 3 doses of 3 mg/kg to 10 mg/kg [3/10 mg/kg] or after 3 doses of 5 mg/kg to 10 mg/kg [5/10 mg/kg].
  • Time to Relapse [ Time Frame: Up to Week 104 ]
    Time to relapse describes the time frame from baseline when the tumor volume increases again after the treatment with MCS110. To be considered a relapse tumor volume had to increase greater than 50% of the difference between tumor volume at baseline and the lowest tumor volume measured by MRI. In this assessment the Part B and Part C patients were analyzed separately. N/A (not available):Data analysis not performed as sample size was not analyzable as no patient had surgery/relapse.
  • Time to Surgery [ Time Frame: Up to Week 104 ]
    Time to surgery describes the time frame from baseline to the time point when participants had surgical removement of PVNS tumor. This could be either residual tumor after the tumor volume was reduced or surgery due to relapse. In this assessment the Part B and Part C patients were analyzed separately. Not Available (NA): Data analysis not performed as sample size was not analyzable as no patient had surgery.
  • Average of Health-Related Quality of Life Questionnaire Score for mHAQ [ Time Frame: up to 104 weeks ]
    The mHAQ assesses 20 activities in 8 categories related to daily life, which are rated on a 4-point Likert scale. The mHAQ is calculated as the average of the single scores with the following scoring: without difficulty =0; with some difficulty =1; with much difficulty =2; unable to do =3. Total score is between 0 - 3.0. Values <0.3 are considered normal. Data presented include only participants, who received multiple doses of MCS110.
  • Number of CD14+ Monocytes and Number of CD14 + Monocytes and CD16+ Monocytes [ Time Frame: Baseline Up to Week 104 ]
    Blood samples were collected for the evaluation of CD14+ monocytes (using FACS) and CD14+ CD16+ monocytes. Based on preliminary analysis, the quality of the samples did not allow meaningful conclusions to be drawn. Thus, in Part B, the monocyte sample collection was discontinued.
  • Change From Baseline Per Treatment for Activities of Daily Living (ADL) in the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study) ]
    The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life (QOL), pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
  • Change From Baseline Per Treatment for Knee Related Quality of Life in the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study) ]
    The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
  • Change From Baseline Per Treatment for Pain and Discomfort in the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study) ]
    The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
  • Change From Baseline Per Treatment for Sport/Recreation in the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study) ]
    The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
  • Change From Baseline Per Treatment for Symptoms in the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline, Week 4, Week 12, Week 24, Week 48, Week 40, Week 72, Week 104 (end of study) ]
    The KOOS is a patient-reported outcome measurement instrument developed to assess the subject's opinion about their knee and associated problems. The KOOS questionnaire collected data on 5 knee-specific patient-centered outcomes: activities of daily life (ADL), knee related quality of life, pain and discomfort, sport/recreation, symptoms. The 5 KOOS sub-scales were scored separately on a Likert scale scored from 0 (no problems) to 4 (extreme problems) and scores were transformed to a 0.100 scale with 0 representing extreme knee problems and 100 representing no problems. The 5 dimensions were analyzed independently. Positive changes (i.e. increases in the score) are beneficial. KOOS was assessed in Part B and C only in participants with knee PVNS tumor.
  • Change From Baseline Per Treatment Using EuroQol-5 Dimensional (EQ-5D VAS)Visual Analog Scale Quality of Life Questionnaire [ Time Frame: Week 4, Week 24, up to 104 weeks ]
    The EQ-5D is a standardized measure of health status. The EQ visual analogue scale (EQ VAS)has a range from 0-100: worst possible to perfect health. Data show the absolute change from baseline of EQ5D VAS and at the different visits for participants, who received multiple doses of MCS110. (PART B and PART C).
Original Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2012)
  • Pharmacokinetics of MCS110 and best estimates for key PK parameters including [not limited to] area under the serum concentration-time curve (AUC), clearance (CL), apparent volume of distribution (V), mean residence time (MRT), half-lives (T1/2), etc [ Time Frame: up to 24 weeks or up to 18 weeks ]
    Pharmacokinetic characterization of a single dose of MCS110
  • Evaluation of macrophage-colony stimulating factor (MCSF) plasma concentrations over time [ Time Frame: up to 24 weeks or up to 18 weeks ]
    Pharmacodynamic characterization of a single dose of MCS110
  • Change in Serum C-terminal Type 1 collagen peptide concentrations [ Time Frame: up to 24 weeks or up to 18 weeks ]
    Pharmacodynamic characterization of a single dose of MCS110
  • Number of CD14+ monocytes [ Time Frame: up to 24 weeks or up to 18 weeks ]
    Pharmacodynamic characterization of a single dose of MCS110
  • Number of CD14+ CD16+ monocytes [ Time Frame: up to 24 weeks or up to 18 weeks ]
    Pharmacodynamic characterization of a single dose of MCS110
  • Change in Joint range of motion score [ Time Frame: up to 24 weeks or up to 18 weeks ]
    Assessment of the duration of the clinical response
  • Change in Western Ontario-McMaster Arthritis (WOMAC) score [ Time Frame: up to 24 weeks or up to 18 weeks ]
    Assessment of the duration of the clinical response
  • Change in serum anti-MCS110 antibody concentrations [ Time Frame: up to 24 weeks or up to 18 weeks ]
    Assessment of the immunogenicity
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
Official Title  ICMJE A Phase II Randomized, Double -Blind, Placebo Controlled Study to Assess Safety, Tolerability and Effect on Tumor Size of MCS110 in Patients With Pigmented Villonodular Synovitis (PVNS)
Brief Summary This study, designed as a proof of concept study of MCS110 in pigmented villonodular synovitis, assessed the clinical response to MCS110 treatment in Pigmented Villonodular Synovitis (PVNS) patients, after a single or multiple intravenous doses of MCS110, using magnetic resonance imaging to assess tumor volume, and evaluated the pharmacokinetics/pharmacodynamics, safety and tolerability in this population.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pigmented Villonodular Synovitis
  • PVNS
  • Giant Cell Tumor of the Tendon Sheath
  • GCCTS
  • Tenosynovial Giant Cell Tumor Localized or Diffused Type
  • GCTS
Intervention  ICMJE
  • Drug: MCS110
    Patients will receive up to 6 doses of MCS110 (3 or 5 or 10mg/kg) administered intravenously once every 4 weeks. Before each dosing, safety will be assessed.
    Other Name: Intravenous infusion of MCS110.
  • Drug: Placebo
    Participants will receive a single dose of NaCl on day 1 through intravenous infusion.
    Other Name: Intravenous infusion of placebo.
Study Arms  ICMJE
  • Experimental: MCS110
    Participants will receive a single dose of 10mg/kg on day 1 administered by regular infusion.
    Intervention: Drug: MCS110
  • Placebo Comparator: Placebo
    Part A: single-dose placebo to match MCS110 (10 mg/kg, 1 h i.v. infusion) Part B: single dose placebo to match MCS110 (10 mg/kg, 1 h i.v. infusion administered i.v. at Day 1, followed by 6 doses of placebo to match MCS110 (10 mg/kg)
    Intervention: Drug: Placebo
  • Experimental: MCS110 3 mg/kg
    Part C: MCS110 3 mg/kg (i.v. infusion)
    Intervention: Drug: MCS110
  • Experimental: MCS110 5 mg/kg
    Part C: MCS110 5 mg/kg (i.v. infusion)
    Intervention: Drug: MCS110
  • Experimental: MCS110 10 mg/kg
    Part C: MCS110 10 mg/kg (i.v. infusion)
    Intervention: Drug: MCS110
  • Experimental: MCS110 3 mg/kg & MCS110 10mg/kg
    Part C: MCS110 3 mg/kg (i.v. infusion) & MCS110 10 mg/kg (i.v. infusion)
    Intervention: Drug: MCS110
  • Experimental: MCS110 5 mg/kg & MCS110 10mg/kg
    Part C: MCS110 5 mg/kg (i.v. infusion) & MCS110 10 mg/kg (i.v. infusion)
    Intervention: Drug: MCS110
Publications * Blay JY, El Sayadi H, Thiesse P, Garret J, Ray-Coquard I. Complete response to imatinib in relapsing pigmented villonodular synovitis/tenosynovial giant cell tumor (PVNS/TGCT). Ann Oncol. 2008 Apr;19(4):821-2. doi: 10.1093/annonc/mdn033. Epub 2008 Feb 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2018)
36
Original Estimated Enrollment  ICMJE
 (submitted: July 16, 2012)
12
Actual Study Completion Date  ICMJE December 21, 2018
Actual Primary Completion Date December 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  • Males and Females aged ≥ 18 years (≥ 12 years in PART C) with PVNS or GCTTS with, at least, one measurable site of disease on MRI.
  • Patients expected to get surgery (PART A of study only).
  • Vital signs within the ranges: systolic blood pressure 80-150 mmHg , diastolic blood pressure 50-100 mmHg, pulse rate 40-100 bpm, oral body temperature 35.0-37.5°C.
  • Patients with normal level of serum ionized calcium and phosphate.
  • Women of child-bearing potential must use highly effective contraception during the study and for 84 days after the study drug infusion.

Exclusion criteria:

  • Patients with major surgery less than 3 months prior to start study drug or who have still side effects of such therapy.
  • Presence of systemic illness precluding definitive surgery or increasing the risk to patients due to potential immunosuppression.
  • Use previously of intra-articular treatment within 4 weeks prior dosing.
  • Patients with dermal change indicative of lymphedema or phlebolymphedema. disease.
  • Patients with elevated troponin T and/or CK levels (> 1.5 x ULN for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease.
  • Patients receiving immunosuppressive treatment as well as corticosteroids which cannot be discontinued at least 4 weeks before dosing.
  • Patients engaged in a resistance exercise training program.
  • Patients with pacemakers or any metallic objects as exclusion for MRI
  • Patients with concomitant disease know to get influence on bone metabolism
  • Patients who have history of drug or alcohol abuse within 12 months prior study dosing.
  • Pregnant or nursing (lactating) women.

Other protocol-defined inclusion/exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland,   United States
Removed Location Countries Germany
 
Administrative Information
NCT Number  ICMJE NCT01643850
Other Study ID Numbers  ICMJE CMCS110X2201
2011-002951-32 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP