Clinical Trial Details

NCT ID: NCT02552212
Date Last Changed: April 13, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of Certolizumab Pegol and Placebo to evaluate Axial Spondyloarthritis, Nonradiographic Axial Spondyloarthritis or Nr-axSpA

Research Study Title

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

Purpose

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.

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Recruitment Details

Phase
3
Gender
All
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
UCB BIOSCIENCES GmbH
Duration
27 Months
Facility Type
N/A
Compensation

Eligibility

All ages 18 Years and up

Inclusion Criteria:

  • At least 18 years old at the start of Screening Visit

  • A documented diagnosis of adult-onset axial SpondyloArthritis (axSpA) as defined by the specified Assessment of SpondyloArthritis International Society (ASAS) criteria with at least 12 months symptom duration 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, or contraindication to, or intolerant to at least 2 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)

Exclusion Criteria:

  • Diagnosis of any other Inflammatory Arthritis

  • Prior treatment with any experimental biological agents for treatment of Axial SpondyloArthritis (SpA)

  • Exposure to more than 1 TNF-antagonist or primary failure to TNF antagonist therapy

  • History of or current chronic or recurrent infections

  • High risk of infection

  • 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

Site Locations (107)

Country State City Zip Facility and Contact
United States Alabama Birmingham As0006 125
United States Arizona Tucson As0006 115
United States California Beverly Hills As0006 155
United States California Fullerton As0006 157
United States California Palm Desert As0006 101
United States California San Francisco As0006 143
United States Connecticut New Haven As0006 160
United States Florida Daytona As0006 117
United States Florida Debrary As0006 116
United States Florida Fort Lauderdale As0006 124
United States Florida New Port Richey As0006 133
United States Florida Plantation As0006 138
United States Florida Tampa As0006 134
United States Florida Vero Beach As0006 106
United States Georgia Atlanta As0006 148
United States Idaho Idaho Falls As0006 137
United States Maryland Cumberland As0006 102
United States Maryland Cumberland As0006 141
United States Maryland Wheaton As0006 111
United States Massachusetts Boston As0006 127
United States Massachusetts Worcester As0006 147
United States Minnesota Eagan As0006 110
United States Minnesota Rochester As0006 123
United States Missouri St. Louis As0006 103
United States New York Brooklyn As0006 114
United States New York New York As0006 256
United States North Carolina Charlotte As0006 118
United States Oklahoma Oklahoma As0006 149
United States Oregon Portland As0006 105
United States Pennsylvania Duncansville As0006 108
United States Pennsylvania Philadelphia As0006 144
United States Pennsylvania West Reading As0006 129
United States South Carolina Orangeburg As0006 156
United States Texas Corpus Christi As0006 159
United States Utah Salt Lake City As0006 107
United States Washington Seattle As0006 104
United States Wisconsin Manitowoc As0006 158
United States Wisconsin Onalaska As0006 113
Australia New South Wales Coffs Harbour As0006 210
Australia Queensland Maroochydore As0006 209
Australia Tasmania Hobart As0006 205
Australia Victoria Malvern As0006 201
Australia Camperdown As0006 208
Australia Footscray As0006 204
Australia Victoria Park As0006 202
Bulgaria Plovdiv As0006 305
Bulgaria Ruse As0006 304
Bulgaria Sevlievo As0006 306
Bulgaria Sofia As0006 300
Bulgaria Sofia As0006 302
Bulgaria Sofia As0006 307
Bulgaria Sofia As0006 309
Bulgaria Varna As0006 308
Canada British Columbia Victoria As0006 150
Canada Edmonton As0006 152
Czech Republic Hlucin As0006 326
Czech Republic Hradec Kralove As0006 332
Czech Republic Hustopece As0006 324
Czech Republic Olomouc As0006 327
Czech Republic Ostrava As0006 320
Czech Republic Ostrava As0006 333
Czech Republic Pardubice As0006 322
Czech Republic Praha 2 As0006 328
Czech Republic Praha As0006 323
Czech Republic Praha As0006 329
Czech Republic Praha As0006 330
Czech Republic Zlin As0006 331
Hungary Balatonfuered As0006 365
Hungary Budapest As0006 362
Hungary Budapest As0006 363
Hungary Szekesfehervar As0006 361
Poland Bydgoszcz As0006 406
Poland Elblag As0006 400
Poland Krakow As0006 401
Poland Krakow As0006 402
Poland Lublin As0006 411
Poland Poznan As0006 403
Poland Poznan As0006 404
Poland Torun As0006 405
Poland Warszawa As0006 407
Poland Warszawa As0006 408
Poland Warszawa As0006 409
Poland Warszawa As0006 410
Poland Wroclaw As0006 413
Poland Wroclaw As0006 414
Russian Federation Chelyabinsk As0006 461
Russian Federation Kazan As0006 450
Russian Federation Kazan As0006 451
Russian Federation Kemerovo As0006 458
Russian Federation Moscow As0006 453
Russian Federation Moscow As0006 455
Russian Federation Orenburg As0006 462
Russian Federation Ryazan As0006 452
Russian Federation Saint Petersburg As0006 463
Russian Federation Samara As0006 465
Russian Federation Saratov As0006 454
Russian Federation Sevastopol As0006 466
Russian Federation Smolensk As0006 459
Russian Federation Smolensk As0006 460
Russian Federation St. Petersburg As0006 464
Russian Federation St. Petersburg As0006 467
Russian Federation Tolyatti As0006 456
Russian Federation Yaroslav As0006 457
Taiwan Hualien As0006 232
Taiwan Taichung As0006 230
Taiwan Taichung As0006 233
Taiwan Taipei As0006 231

Contact

UCB Cares
+1 877 8229493

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