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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01392326
Registration number
NCT01392326
Ethics application status
Date submitted
7/07/2011
Date registered
12/07/2011
Date last updated
4/02/2016
Titles & IDs
Public title
Efficacy at 24 Weeks and Long Term Safety, Tolerability and Efficacy up to 2 Years of Secukinumab (AIN457) in Patients With Active Psoriatic Arthritis (PsA)
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Secukinumab to Demonstrate the Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 2 Years in Patients With Active Psoriatic Arthritis
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Secondary ID [1]
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2011-000276-34
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Secondary ID [2]
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CAIN457F2306
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Universal Trial Number (UTN)
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Trial acronym
FUTURE 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Psoriatic Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Musculoskeletal
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Other muscular and skeletal disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Secukinumab (75 mg)
Treatment: Drugs - Secukinumab (150 mg)
Treatment: Drugs - Placebo Comparator
Experimental: Group 1 - Secukinumab (75mg)
Experimental: Group 2 - Secukinumab (150 mg)
Placebo comparator: Group 3 -
Treatment: Drugs: Secukinumab (75 mg)
Secukinumab (75 mg)
Treatment: Drugs: Secukinumab (150 mg)
Secukinumab (150 mg)
Treatment: Drugs: Placebo Comparator
Placebo Comparator
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percent of Patients Achieving ACR20 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
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Assessment method [1]
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A patient will be considered as improved according the ACR20 criteria if she/he has at least 20 % improvement in the two following measures:Tender joint count,Swollen joint count and at least 3 of the following 5 measures: Patient's assessment of pain, Patient's global assessment disease activity,Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score,Acute phase reactant (hsCRP or ESR)
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Percent of Subjects Achieving a PASI75 Response in the Subgroup of Subjects Who Have =3% Skin Involvement With Psoriasis at Baseline
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Assessment method [1]
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A 75% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 75) is the current benchmark of primary endpoints for most clinical trials with end points of psoriasis
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Percent of Subjects Achieving a PASI90 Response in the Subgroup of Subjects Who Have =3% Skin Involvement With Psoriasis at Baseline
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Assessment method [2]
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A 90% reduction in the Psoriasis Area and Severity Index (PASI) score (PASI 90) is above the current benchmark of primary endpoints for most clinical trials with endpoints of psoriasis
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Change From Baseline in DAS28-CRP for Secukinumab 75 or 150 mg
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Assessment method [3]
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DAS-CRP values range from 2.0 to 10.0 while higher values mean a higher disease activity. A DAS-CRP below the value of 2.6 is interpreted as Remission.DAS28 the DAS-CRP uses 28 different joints for its calculation: proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2) With the above mentioned parameters, DAS-CRP is calculated as: \<math\>DAS-CRP=0.56 \\times \\sqrt{TEN28} + 0.28 \\times \\sqrt{SW28} + 0.36 \\times \\ln(CRP+1) + 0.014 \\times SA+0.96\</math\> With: TEN28: number of joints with tenderness upon touching SW28: number of swollen joints CRP: C-reactive Protein SA: subjective assessment of disease activity by the patient during the preceding 7 days on a scale betweenn 0 and 100 ("0":no activity, "100": highest activity possible)
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Timepoint [3]
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Week 24
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Secondary outcome [4]
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Change From Baseline in SF36-PCS for Secukinumab 75 or 150 mg
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Assessment method [4]
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The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
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Timepoint [4]
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Week 24
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Secondary outcome [5]
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Change From Baseline in HAQ-DI for Secukinumab 75 or 150 mg
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Assessment method [5]
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HAQ-DI, assesses a patient's level of functional ability and includes questions of fine movements of the upper extremity, locomotor activities of the lower extremity, and activities that involve both upper and lower extremities. There are 20 questions in eight categories of functioning which represent a comprehensive set of functional activities - dressing, rising, eating, walking, hygiene, reach, grip, and usual activities. The stem of each item asks over the past week "Are you able to ..." perform a particular task. The patient's responses are made on a scale from zero (no disability) to three (completely disabled).
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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Percent of Patients Achieving ACR50 Response Criteria on Secukinumab 75 or 150 mg vs. Placebo
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Assessment method [6]
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ACR50 = 50 % improvement in at least 3 of the 5 measures( Patient's assessment of pain, Patient's global assessment of disease activity, Physician's global assessment of disease activity, Health Assessment Questionnaire (HAQ©) score, C-reactive protein (CRP)/Erythrocyte Sedimentation Rate (ESR) and 50 % improvement in the swollen and tender joint count.
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Timepoint [6]
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Week 24
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Secondary outcome [7]
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Change From Baseline for Joint/Bone Structural Damage (Van Der Heijde Modified Total Sharp Score) for Secukinumab 75 and 150 mg (Pooled Doses)
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Assessment method [7]
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Measured are 44 joints for erosions: scored 0 to 5 in hands; 0 to 10 in feet;40 joints for joint space narrowing; summed for total score by two experienced readers scored every film blinded to patient identity, treatment, sequence of film. Lower score equals better outcome. With score of zero being normal. Joint structural damage change from baseline at Week 24 using non-parametric ANCOVA, Linear extrapolation. Estimate (for the difference in mean), SE are from a non-parametric ANCOVA model with the change from baseline van der Heijde total modified Sharp score as the dependent variable, treatment and randomization stratum (TNFa status -naive or IR ) as factors, and weight and baseline van der Heijde total modified Sharp score as covariates.
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Percent of Patients With Dactylitis in the Subset of Subjects Who Have Dactylitis at Baseline
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Assessment method [8]
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Timepoint [8]
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Week 24
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Secondary outcome [9]
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Percent of Patients With Enthesitis in the Subset of Subjects Who Have Enthesitis at Baseline
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Assessment method [9]
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Timepoint [9]
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Week 24
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Eligibility
Key inclusion criteria
Inclusion criteria:
* Male or non-pregnant, non-lactating female patients at least 18 years of age
* Diagnosis of PsA classified by CASPAR criteria and with symptoms for at least 6 months with moderate to severe PsA who must have at Baseline =3 tender joints out of 78 and =3 swollen out of 76 (dactylitis of a digit counts as one joint each)
* Rheumatoid factor and anti-CCP antibodies negative
* Diagnosis of active plaque psoriasis, with at least one psoriatic plaque of =2cm diameter or nail changes consistent with psoriasis or documented history o plaque psoriasis
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
* Chest X-ray with evidence of ongoing infectious or malignant process
* Subjects who have previously been treated with more than 3 different TNFa inhibitors
* Subjects taking high potency opioid analgesics
* Subjects who have ever received biologic immunomodulating agents except for those targeting TNFa Other protocol-defined inclusion/exclusion criteria may apply
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2011
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/10/2014
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Sample size
Target
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Accrual to date
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Final
606
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Recruitment in Australia
Recruitment state(s)
QLD,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Maroochydore
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Recruitment hospital [2]
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Novartis Investigative Site - Malvern
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Recruitment postcode(s) [1]
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4558 - Maroochydore
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Recruitment postcode(s) [2]
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3144 - Malvern
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
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Name
Novartis Pharmaceuticals
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Ethics approval
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Summary
Brief summary
This study will assess the efficacy and safety of secukinumab in patients with active psoriatic arthritis who are intolerant to or have had an inadequate response to NSAIDs, DMARDs and / or TNFa inhibitor therapy.
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Trial website
https://clinicaltrials.gov/study/NCT01392326
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Trial related presentations / publications
Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pellet P, Delicha EM, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol. 2020 Jan;2(1):18-25. doi: 10.1002/acr2.11097. Epub 2019 Nov 14. Deodhar A, Gladman DD, McInnes IB, Spindeldreher S, Martin R, Pricop L, Porter B, Safi J Jr, Shete A, Bruin G. Secukinumab Immunogenicity over 52 Weeks in Patients with Psoriatic Arthritis and Ankylosing Spondylitis. J Rheumatol. 2020 Apr;47(4):539-547. doi: 10.3899/jrheum.190116. Epub 2019 Jun 15. Kavanaugh A, Mease PJ, Reimold AM, Tahir H, Rech J, Hall S, Geusens P, Wang Z, Pricop L, Mpofu S; FUTURE-1 Study Group. Secukinumab for Long-Term Treatment of Psoriatic Arthritis: A Two-Year Followup From a Phase III, Randomized, Double-Blind Placebo-Controlled Study. Arthritis Care Res (Hoboken). 2017 Mar;69(3):347-355. doi: 10.1002/acr.23111. Strand V, Mease P, Gossec L, Elkayam O, van den Bosch F, Zuazo J, Pricop L, Mpofu S; FUTURE 1 study group. Secukinumab improves patient-reported outcomes in subjects with active psoriatic arthritis: results from a randomised phase III trial (FUTURE 1). Ann Rheum Dis. 2017 Jan;76(1):203-207. doi: 10.1136/annrheumdis-2015-209055. Epub 2016 May 11. Mease PJ, McInnes IB, Kirkham B, Kavanaugh A, Rahman P, van der Heijde D, Landewe R, Nash P, Pricop L, Yuan J, Richards HB, Mpofu S; FUTURE 1 Study Group. Secukinumab Inhibition of Interleukin-17A in Patients with Psoriatic Arthritis. N Engl J Med. 2015 Oct;373(14):1329-39. doi: 10.1056/NEJMoa1412679.
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Public notes
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Contacts
Principal investigator
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01392326
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