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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01989468
Registration number
NCT01989468
Ethics application status
Date submitted
7/11/2013
Date registered
21/11/2013
Date last updated
16/04/2019
Titles & IDs
Public title
24 Week Efficacy and 3-year Safety and Efficacy of Secukinumab in Active Psoriatic Arthritis
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Scientific title
A Phase III, Randomized, Double-blind, Placebo-controlled Multicenter Study of Subcutaneous Secukinumab in Autoinjectors, to Demonstrate Efficacy at 24 Weeks and to Assess the Long Term Safety, Tolerability and Efficacy up to 3 Years in Subjects With Active Psoriatic Arthritis
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Secondary ID [1]
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2013-004002-25
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Secondary ID [2]
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CAIN457F2318
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Universal Trial Number (UTN)
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Trial acronym
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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
Other interventions - Secukinumab
Other interventions - Placebo
Experimental: Secukinumab (AIN457) 150 mg s.c. - 1 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Experimental: Secukinumab (AIN457) 300 mg s.c. - 2 s.c. Secukinumab 150 mg autoinjector at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Placebo Comparator: Placebo - Matching Placebo at Baseline, Weeks 1, 2, 3, 4, followed by dosing every four weeks starting at Week 4.
Other interventions: Secukinumab
Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)
Other interventions: Placebo
Secukinumab placebo provided in 1 mL autoinjector
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Intervention code [1]
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Other interventions
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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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Proportion of Patients Achieving American College of Rheumatology 20 (ACR20) Response Criteria on Secukinumab Versus Placebo at Week 24
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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% decrease in the swollen and tender joint count, and at least 20% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]
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Timepoint [1]
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Week 24
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Secondary outcome [1]
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Proportion of Patients Achieving American College of Rheumatology 50 (ACR50) Response Criteria on Secukinumab Versus Placebo at Week 24
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Assessment method [1]
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A patient will be considered as improved according the ACR50 criteria if she/he has at least 50% decreases in the swollen and tender joint count, and at least 50% improvements in 3 of the following 5 criteria: physical disability on the Health Assessment Questionnaire; pain score on a visual analog scale; patient global assessment; physician global assessment; and acute phase reactant [either erythrocyte sedimentation rate (ESR) or high sensitivity C-reactive protein (hsCRP)]
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Timepoint [1]
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Week 24
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Secondary outcome [2]
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Change From Baseline in Disease Activity Score for 28 Joints (DAS28-CRP) (Utilizing hsCRP) in Subjects Treated With Secukinumab Versus Placebo at Week 24
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Assessment method [2]
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DAS28-CRP is a measure of disease activity based on 28-Swollen and Tender Joint Count [proximal interphalangeal joints (10 joints) metacarpophalangeal joints (10) wrists (2) elbows (2) shoulders (2) knees (2)], CRP, and the Patient's Global Assessment of disease activity. Values range from 2.0 to 10.0 where higher values mean a higher disease activity. DAS28-CRP < 2.6 is interpreted as remission.
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Timepoint [2]
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Week 24
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Secondary outcome [3]
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Proportion of Subjects Achieving a Psoriatic Area and Severity Index 75 (PASI75) Response in Subjects on Secukinumab Versus Placebo at Week 24
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Assessment method [3]
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PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI75 represents an improvement in the PASI score of at least 75% as compared with baseline.
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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 Physical Function Component of the Short-form Health Survey (SF-36-PCS) in Subjects Treated With Secukinumab Versus Placebo at Week 24
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Assessment method [4]
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SF-36 is a 36 item questionnaire which measures Quality of Life across eight domains, which are both physically and emotionally based. Two overall summary scores, the Physical Component Summary (PCS) and Mental Component Summary (MCS) can be computed. In this study, SF-36 PCS is used to assess improvement from baseline of at least one dose of secukinumab versus placebo. The SF-36 is a validated instrument measuring health-related quality of life across multiple disease states. It has 36 questions with 8 subscale scores and 2 summary scores (1) physical component summary=physical functioning, role-physical, bodily pain, and general health. There is no total overall score; scoring is done for both subscores and summary scores. For subscores and summary scores, 0 =worst score (or quality of life) and 100=best score. Change from Baseline= post-Baseline - Baseline value.
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Timepoint [4]
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Week 24
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Secondary outcome [5]
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Percentage of Subjects Achieving a Psoriatic Area and Severity Index 90 (PASI90) Response in Subjects Treated With Secukinumab Versus Placebo at Week 24
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Assessment method [5]
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PASI takes into account the extent of the disease, as well as the severity of erythema, scaling, and thickness in different body areas affected by psoriasis. A PASI90 represents an improvement in the PASI score of at least 90% as compared with baseline.
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Timepoint [5]
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Week 24
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Secondary outcome [6]
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Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI Score) in Subjects Treated With Secukinumab Versus Placebo at Week 24
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Assessment method [6]
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The HAQ measures physical disability and functional status. It has 4 dimensions: disability, pain, drug side effects and dollar costs. In this trial, only the disability dimension was used. The disability dimension consists of 20 multiple choice items concerning difficulty in performing 8 common activities of daily living; dressing and grooming, arising, eating, walking, reaching, personal hygiene, gripping and activities. Participants choose from four response categories: 0 (without any difficulty), 1 (with some difficulty), 2 (with much difficulty) and 3 (unable to do). Within each of the 8 categories, only the item indicating the most severe impairment contributes to the category score. The HAQ score is calculated by summing the computed scores for each category and dividing by the number of categories answered. It ranges from 0 (without any difficulty) to 3 (unable to do). A negative change from baseline indicates improvement.
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Timepoint [6]
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Week 24
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Secondary outcome [7]
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Proportion of Patients With Dactylitis at Week 24 in the Subset of Patients Who Had Dactylitis at Baseline
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Assessment method [7]
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The presence of dactylitis was assessed by dactylitis count (number of fingers and toes with dactylitis, with a range of 0-20). If dactylitis is present with any finger or toe, the patient is counted as a patient with dactylitis.
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Timepoint [7]
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Week 24
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Secondary outcome [8]
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Proportion of Patients With Enthesitis at Week 24 in the Subset of Patients Who Had Enthesitis at Baseline
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Assessment method [8]
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The presence of Enthesitis was assessed using a validated enthesitis index that uses 6 sites for evaluation of enthesitis: lateral epicondyle humerus L + R, proximal achilles L + R and medial condyle femur. If enthesitis is present at any of the 6 sites, the subject is counted as a subject with enthesitis.
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Timepoint [8]
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Week 24
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Secondary outcome [9]
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Number of Participants With Treatment Emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by Primary System Organ Class (SOC)
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Assessment method [9]
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Analysis of frequencies for treatment emergent Adverse Event (AE), Serious Adverse Event (SAE) and Deaths by primary System Organ Class (SOC).
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Timepoint [9]
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From first dose of study treatment to last study visit, up to 3 years
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Eligibility
Key inclusion criteria
- Diagnosis of Psoriatic Arthritis (PsA) classified by ClASsification criteria for
Psoriatic ARthritis (CASPAR) criteria.
- Rheumatoid factor and anti-cyclic citrullinated peptide (CCP) antibodies negative.
- Diagnosis of active plaque psoriasis or nail changes consistent with psoriasis.
- Inadequate control of symptoms with NSAID.
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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
- Chest X-ray or chest magnetic resonance imaging (MRI) with evidence of ongoing
infectious or malignant process.
- Subjects taking high potency opioid analgesics.
- Previous exposure to secukinumab or other biologic drug directly targeting
interleukin-17 (IL-17) or IL-17 receptor.
- Ongoing use of prohibited psoriasis treatments / medications.
- Subjects who have ever received biologic immunomodulating agents except for those
targeting TNFa.
- Previous treatment with any cell-depleting therapies.
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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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Type of endpoint/s
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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
10/04/2014
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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
28/03/2018
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Sample size
Target
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Accrual to date
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Final
414
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,TAS,VIC
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Recruitment hospital [1]
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Novartis Investigative Site - Kogarah
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Recruitment hospital [2]
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Novartis Investigative Site - Maroochydore
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Recruitment hospital [3]
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Novartis Investigative Site - Hobart
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Recruitment hospital [4]
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Novartis Investigative Site - Malvern East
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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4558 - Maroochydore
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Recruitment postcode(s) [3]
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7000 - Hobart
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Recruitment postcode(s) [4]
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3145 - Malvern East
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Recruitment outside Australia
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United States of America
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Florida
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Indiana
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Novartis Pharmaceuticals
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to provide 24 - 52 week efficacy, safety and tolerability data,
and up to 3-year efficacy, safety and tolerability data in subjects with active Psoriatic
Arthritis despite current or previous nonsteroidal anti-inflammatory drug (NSAID),
disease-modifying antirheumatic drug (DMARD) therapy and/or previous anti-tumor necrosis
factor alpha (TNFa) therapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01989468
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Trial related presentations / publications
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01989468
Download to PDF