Multicenter Study Evaluating Certolizumab Pegol Compared to Placebo in Subjects With axSpA Without X-ray Evidence of AS (C-AXSPAND)

August 16, 2022 updated by: UCB BIOSCIENCES GmbH

Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis (axSpA) Without X-Ray Evidence of Ankylosing Spondylitis (AS) and Objective Signs of Inflammation

Patients with active Axial Spondyloarthritis without x-ray evidence of Ankylosing Spondylitis and with signs of inflammation will be randomly assigned to receive certolizumab pegol (CZP) 200 mg every two weeks or placebo. The primary objective is to demonstrate the efficacy of CZP in these patients.

Study Overview

Study Type

Interventional

Enrollment (Actual)

317

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Camperdown, Australia
        • As0006 208
      • Coffs Harbour, Australia
        • As0006 210
      • Footscray, Australia
        • As0006 204
      • Malvern East, Australia
        • As0006 201
      • Maroochydore, Australia
        • As0006 209
      • South Hobart, Australia
        • As0006 205
      • Victoria Park, Australia
        • As0006 202
      • Plovdiv, Bulgaria
        • As0006 302
      • Plovdiv, Bulgaria
        • As0006 305
      • Ruse, Bulgaria
        • As0006 304
      • Sevlievo, Bulgaria
        • As0006 306
      • Sofia, Bulgaria
        • As0006 300
      • Sofia, Bulgaria
        • As0006 307
      • Sofia, Bulgaria
        • As0006 309
      • Varna, Bulgaria
        • As0006 308
      • Edmonton, Canada
        • As0006 152
      • Victoria, Canada
        • As0006 150
      • Hlučín, Czechia
        • As0006 326
      • Hustopeče, Czechia
        • As0006 324
      • Olomouc, Czechia
        • As0006 327
      • Ostrava, Czechia
        • As0006 320
      • Pardubice, Czechia
        • As0006 322
      • Praha, Czechia
        • As0006 323
      • Praha, Czechia
        • As0006 329
      • Praha, Czechia
        • As0006 330
      • Praha 2, Czechia
        • As0006 328
      • Příbor, Czechia
        • As0006 333
      • Rychnov Nad Kněžnou, Czechia
        • As0006 332
      • Zlín, Czechia
        • As0006 331
      • Balatonfüred, Hungary
        • As0006 365
      • Budapest, Hungary
        • As0006 362
      • Budapest, Hungary
        • As0006 363
      • Szekesfehervar, Hungary
        • As0006 361
      • Bydgoszcz, Poland
        • As0006 406
      • Elbląg, Poland
        • As0006 400
      • Kraków, Poland
        • As0006 401
      • Kraków, Poland
        • As0006 402
      • Lublin, Poland
        • As0006 411
      • Poznań, Poland
        • As0006 403
      • Poznań, Poland
        • As0006 404
      • Toruń, Poland
        • As0006 405
      • Warszawa, Poland
        • As0006 407
      • Warszawa, Poland
        • As0006 408
      • Warszawa, Poland
        • As0006 409
      • Warszawa, Poland
        • As0006 410
      • Wrocław, Poland
        • As0006 413
      • Wrocław, Poland
        • As0006 414
      • Chelyabinsk, Russian Federation
        • As0006 461
      • Ivanovo, Russian Federation
        • As0006 453
      • Kazan, Russian Federation
        • As0006 450
      • Kazan, Russian Federation
        • As0006 451
      • Kemerovo, Russian Federation
        • As0006 458
      • Moscow, Russian Federation
        • As0006 455
      • Moscow, Russian Federation
        • As0006 466
      • Orenburg, Russian Federation
        • As0006 462
      • Ryazan', Russian Federation
        • As0006 452
      • Saint Petersburg, Russian Federation
        • As0006 459
      • Saint Petersburg, Russian Federation
        • As0006 463
      • Saint Petersburg, Russian Federation
        • As0006 464
      • Saint Petersburg, Russian Federation
        • As0006 467
      • Samara, Russian Federation
        • As0006 465
      • Saratov, Russian Federation
        • As0006 454
      • Smolensk, Russian Federation
        • As0006 460
      • Tolyatti, Russian Federation
        • As0006 456
      • Yaroslavl, Russian Federation
        • As0006 457
      • Hualien City, Taiwan
        • As0006 232
      • Taichung City, Taiwan
        • As0006 230
      • Taichung City, Taiwan
        • As0006 233
      • Taipei, Taiwan
        • As0006 231
    • Alabama
      • Birmingham, Alabama, United States
        • As0006 125
    • Arizona
      • Scottsdale, Arizona, United States
        • As0006 120
      • Tucson, Arizona, United States
        • As0006 115
    • California
      • Beverly Hills, California, United States
        • As0006 155
      • Palm Desert, California, United States
        • As0006 101
      • San Francisco, California, United States
        • As0006 143
    • Connecticut
      • New Haven, Connecticut, United States
        • As0006 160
    • Florida
      • Daytona Beach, Florida, United States
        • As0006 117
      • DeBary, Florida, United States
        • As0006 116
      • Fort Lauderdale, Florida, United States
        • As0006 124
      • New Port Richey, Florida, United States
        • As0006 133
      • Plantation, Florida, United States
        • As0006 138
      • Tampa, Florida, United States
        • As0006 134
      • Vero Beach, Florida, United States
        • As0006 106
    • Georgia
      • Atlanta, Georgia, United States
        • As0006 148
    • Idaho
      • Idaho Falls, Idaho, United States
        • As0006 137
    • Maryland
      • Cumberland, Maryland, United States
        • As0006 102
      • Cumberland, Maryland, United States
        • As0006 141
      • Wheaton, Maryland, United States
        • As0006 111
    • Massachusetts
      • Boston, Massachusetts, United States
        • As0006 127
      • Worcester, Massachusetts, United States
        • As0006 147
    • Minnesota
      • Eagan, Minnesota, United States
        • As0006 110
      • Rochester, Minnesota, United States
        • As0006 123
    • Missouri
      • Saint Louis, Missouri, United States
        • As0006 103
    • New York
      • Brooklyn, New York, United States
        • As0006 114
    • North Carolina
      • Charlotte, North Carolina, United States
        • As0006 118
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • As0006 149
    • Oregon
      • Portland, Oregon, United States
        • As0006 105
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
        • As0006 108
      • Philadelphia, Pennsylvania, United States
        • As0006 144
      • Wyomissing, Pennsylvania, United States
        • As0006 129
    • South Carolina
      • Orangeburg, South Carolina, United States
        • As0006 156
    • Utah
      • Salt Lake City, Utah, United States
        • As0006 107
    • Washington
      • Seattle, Washington, United States
        • As0006 104
    • Wisconsin
      • Manitowoc, Wisconsin, United States
        • As0006 158
      • Onalaska, Wisconsin, United States
        • As0006 113

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 18 years old at the start of Screening Visit
  • A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) and meet the Assessment of SpondyloArthritis International Society (ASAS) criteria for axSpA
  • Subjects must have had back pain for at least 12 months before Screening
  • No sacroiliitis defined by Modified New York (mNY) criteria on sacroiliac (SI) x-rays
  • Active disease at Screening as defined by

    • Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score >= 4
    • Spinal pain >= 4 on a 0 to 10 Numerical Rating Scale (NRS)
  • Inadequate response to, have a contraindication to, or have been intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

  • Diagnosis of AS or any other Inflammatory Arthritis
  • Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)
  • Exposure to more than 1 tumor necrosis factor (TNF)-antagonist or primary failure to TNF antagonist therapy
  • History of or current chronic or recurrent infections
  • Subjects with known Tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent Tuberculosis (LTB)
  • Recent live vaccination
  • Concurrent malignancy or a history of malignancy
  • Class III or IV congestive heart failure - New York Heart Association (NYHA)
  • Demyelinating disease of the central nervous system
  • Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product
  • Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Certolizumab Pegol 200 mg Q2W
Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.
  • Active Substance: Certolizumab Pegol
  • Pharmaceutical Form: Prefilled syringe
  • Concentration: 200 mg / ml
  • Route of Administration: Subcutaneous injection
Other Names:
  • Cimzia
  • CDP870
Placebo Comparator: Placebo
Matching placebo to Certolizumab Pegol (CZP) injections are administered every 2 weeks from Week 0 onwards.
  • Active Substance: Placebo
  • Pharmaceutical Form: Prefilled syringe
  • Concentration: 0.9 % saline
  • Route of Administration: Subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Ankylosing Spondylitis Disease Activity Score Major Improvement (ASDAS-MI) Response Criteria Response at Week 52
Time Frame: Week 52

This variable was considered as primary in all countries except for Canada (and any other country where applicable or where requested by Regulatory Authorities) where it was considered as secondary variable.

ASDAS-MI was achieved when there was a reduction (improvement) >= 2.0 in the ASDAS relative to Baseline, or when the lowest possible ASDAS score (0.6) was reached.

The ASDAS was calculated as the sum of the following components:

0.121 × Back pain (BASDAI Q2 result) 0.058 × Duration of morning stiffness (BASDAI Q6 result) 0.110 × Patient's Global Assessment of Disease Activity (PGADA) 0.073 × Peripheral pain/swelling (BASDAI Q3 result) 0.579 × (natural logarithm [ln] of the (CRP [mg/L] + 1)) Back pain, PGADA, duration of morning stiffness, peripheral pain/swelling and fatigue were all assessed on a numerical scale (0 to 10 units, where 0 is "not active" and 10 is "very active").

Week 52
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 12
Time Frame: Week 12

This variable was considered as primary for Canada (and any other country where applicable or where requested by Regulatory Authorities) and as secondary variable in all other countries.

The ASAS40 response was defined as relative improvements of at least 40 % and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.

Week 12
Certolizumab Pegol Plasma Concentration at Baseline
Time Frame: Baseline (Week 0)
Certolizumab pegol plasma concentration was measured at Baseline in micrograms per millilitre (µg/mL).
Baseline (Week 0)
Certolizumab Pegol Plasma Concentration at Week 1
Time Frame: Week 1
Certolizumab pegol plasma concentration was measured at Week 1, in µg/mL.
Week 1
Certolizumab Pegol Plasma Concentration at Week 2
Time Frame: Week 2
Certolizumab pegol plasma concentration was measured at Week 2, in µg/mL.
Week 2
Certolizumab Pegol Plasma Concentration at Week 4
Time Frame: Week 4
Certolizumab pegol plasma concentration was measured at Week 4, in µg/mL.
Week 4
Certolizumab Pegol Plasma Concentration at Week 12
Time Frame: Week 12
Certolizumab pegol plasma concentration was measured at Week 12, in µg/mL.
Week 12
Certolizumab Pegol Plasma Concentration at Week 24
Time Frame: Week 24
Certolizumab pegol plasma concentration was measured at Week 24, in µg/mL.
Week 24
Certolizumab Pegol Plasma Concentration at Week 36
Time Frame: Week 36
Certolizumab pegol plasma concentration was measured at Week 36, in µg/mL.
Week 36
Certolizumab Pegol Plasma Concentration at Week 52
Time Frame: Week 52
Certolizumab pegol plasma concentration was measured at Week 52, in µg/mL.
Week 52
Certolizumab Pegol Plasma Concentration at Follow-Up (FU) Visit
Time Frame: Follow-up Visit (up to Week 60)

Certolizumab pegol plasma concentration was measured at the Follow-Up Visit, in µg/mL.

Follow-Up Visit was defined as 8 weeks after Week 52 or Withdrawal (WD) visit for subjects not participating in the Safety Follow-Up Extension (SFE) Period.

Follow-up Visit (up to Week 60)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Axial SpondyloArthritis International Society 40% Response Criteria (ASAS40) Response at Week 52
Time Frame: Week 52
The ASAS40 response was defined as relative improvements of at least 40% and absolute improvement of at least 2 units on a 0 to 10 Numeric Rating Scale (NRS), where 0 is "not active" and 10 is "very active" in at least 3 of the 4 domains: Patient's Global Assessment of Disease Activity (PGADA), Pain assessment (total spinal pain NRS scores), Function (Bath Ankylosing Spondylitis Functional Index (BASFI)), Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)) questions 5 and 6 concerning morning stiffness intensity and duration) and no worsening at all in the remaining domain.
Week 52
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: From Baseline to Week 12
The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 12
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: From Baseline to Week 52
The BASFI is a validated disease-specific instrument for assessing physical function. The BASFI comprises 10 items relating to the past week. The BASFI is the mean of the 10 scores such that the total score ranges from 0 (Easy) to 10 (Impossible), with lower scores indicating better physical function. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 52
Change From Baseline to Week 12 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: From Baseline to Week 12
The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 12
Change From Baseline to Week 52 in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: From Baseline to Week 52
The BASDAI is a validated self-reported instrument, which consists of six 10 unit horizontal Numeric Rating Scales to measure the disease activity of ankylosing spondylitis (AS) from the subject's perspective. It measures the severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration) over the last week. The final BASDAI scores ranges from 0 (not active) to 10 (very active), with lower scores indicating lower disease activity. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 52
Change From Baseline to Week 12 in Sacroiliac Spondyloarthritis Research Consortium of Canada (SI-SPARCC) Score
Time Frame: From Baseline to Week 12
The Spondyloarthritis Research Consortium of Canada (SPARCC) scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 12
Number of Subjects Without Relevant Changes to Background Medication From Baseline to Week 52
Time Frame: From Baseline to Week 52

The number of subjects who did not have relevant changes to background medications during the study treatment period.

A subject is without relevant changes to background medication if they do not have: the addition of a new disease-modifying antirheumatic drug (DMARD) or the change from one DMAR to another; the addition of an nonsteroidal anti-inflammatory drug (NSAID) or the change from one NSAID to another; an increased dose of chronic corticosteroids; the addition of a new chronic analgesic medication or increased dose in chronic analgesic medication; and they complete double-blind study treatment to Week 52.

From Baseline to Week 52
Change From Baseline in Ankylosing Spondylitis Quality of Life (ASQoL) at Week 52
Time Frame: From Baseline to Week 52
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 52
Change From Baseline in ASQoL at Week 1
Time Frame: From Baseline to Week 1
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 1
Change From Baseline in ASQoL at Week 2
Time Frame: From Baseline to Week 2
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 2
Change From Baseline in ASQoL at Week 4
Time Frame: From Baseline to Week 4
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 4
Change From Baseline in ASQoL at Week 12
Time Frame: From Baseline to Week 12
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 12
Change From Baseline in ASQoL at Week 24
Time Frame: From Baseline to Week 24
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 24
Change From Baseline in ASQoL at Week 36
Time Frame: From Baseline to Week 36
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 36
Change From Baseline in ASQoL at Week 48
Time Frame: From Baseline to Week 48
The ASQoL score ranged from 0 to 18 with higher score indicating worse Health-Related Quality of Life (HRQoL) and 0 indicating good HRQoL. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 48
Change From Baseline in Nocturnal Spinal Pain Numerical Rating Scale (NRS) at Week 52
Time Frame: From Baseline to Week 52
The nocturnal spinal pain experienced by subjects due to AS was measured by following question 'How much pain of your spine due to spondylitis do you have at night?'. The NRS ranged from 0 to 10, where 0 represented 'no pain' and 10 represented 'most severe pain'. The change from Baseline is calculated, a negative value indicating improvement and a positive value worsening.
From Baseline to Week 52
Number of Subjects With Anterior Uveitis (AU) or New AU Flares Through Week 52
Time Frame: Throughout the study conduct (up to Week 52)
The number of subjects with AU or new AU flares during the study treatment period.
Throughout the study conduct (up to Week 52)
Percentage of Subjects With Treatment-Emergent Adverse Events (TEAEs) During the Study
Time Frame: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
Percentage of Subjects With Serious Adverse Events (SAEs) During the Study
Time Frame: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

A serious adverse event (SAE) is any untoward medical occurrence that at any dose:

  • Results in death
  • Is life-threatening
  • Requires in patient hospitalization or prolongation of existing hospitalization
  • Is a congenital anomaly or birth defect
  • Is an infection that requires treatment parenteral antibiotics
  • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
Percentage of Subjects With Adverse Events Leading to Withdrawal From Investigational Medicinal Product (IMP) During the Study
Time Frame: From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)
An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
From Baseline up to the End of Safety Follow-up Extension Period (up to Week 156)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: UCB Cares, 1-844-599-2273 (UCB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

September 15, 2015

First Submitted That Met QC Criteria

September 15, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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