Etanercept Withdrawal And Retreatment Study In Subjects With Non- Radiographic Axial Spondyloarthritis (Chronic Lower Back Pain)
NCT02509026
Last updated date
ABOUT THIS STUDY

The purpose of this study is to investigate the efficacy and the safety of etanercept following withdrawal of etanercept in patients who have achieved a significant clinical response during the first period of the study.
Study Location
Downloads
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Ankylosing Spondylitis
Sex
Females and Males
Age
18-49 years
Inclusion Criteria
Show details
- Male or female 18 to 49 years of age.
- Diagnosis of axial SpA duration of symptoms more than 3 months and less than 5 years back pain with a less than favorable response to NSAIDs.
- Back pain with a less than favorable response to current intake of an NSAID.
- Ability to self-inject investigational product or have a designee who can do so.
Exclusion Criteria
Show details
- Any previous treatment with a tumor necrosis factor-alpha inhibitor, B/T cell inhibitor or other biologic or immunosuppressive agent for a condition other than IBD.
- Known or suspected allergy, hypersensitivity, or contraindication to etanercept.
- Pregnant or breastfeeding; male participants with partners currently pregnant; fertile participants unwilling to use highly effective methods of contraception for the duration of the study and for 28 days after the last dose of the investigational study drug.
Trial Details
Administration
Subcutaneous injections
Placebo
A placebo is not used in this trial
Duration
Follow up: Estimated 28 days
Screening: Estimated 28 weeks
Treatment: Up to 64 weeks
Site Visits
Follow up: visits
Screening: Estimated 3 visits
Treatment: Up to 12 visits
Prior Approval
Yes for different indication in trial country
Post-Trial Access to Study Drug
Not planned
Trial Procedures
Blood test
Keeping a diary
Mri
Physical examination
Questionnaire
Urine test
Vital signs and measurements
X-rays
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Ankylosing SpondylitisA Study of ARRY-371797 in Patients With Active Ankylosing Spondylitis
NCT00811499
- Los Angeles, California
- Chicago, Illinois
- Omaha, Nebraska
- Oklahoma City, Oklahoma
- Portland, Oregon
- Charleston, South Carolina
- Spokane, Washington
- Edmonton, Alberta
- Winnipeg, Manitoba
- Mississauga, Ontario
- Trois-Rivieres, Quebec
- Saskatoon, Saskatchewan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Ankylosing SpondylitisTo Investigate Genetic Factors Associated With the Response to Anti-TNF Therapy in Patients With Early AS
NCT02311842
- Guangzhou, Guangdong
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Ankylosing SpondylitisStudy To Evaluate The Impact Of Early Initiation Of Biological Treatment With Ankylosing Spondylitis
NCT04507763
- Baghdad,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Ankylosing SpondylitisA Study Of Celecoxib Versus Diclofenac In Patients With Ankylosing Spondylitis
NCT02528201
- Bekkestua,
- Bergen,
- Bergen,
- Bodø,
- Bærum Postterminal,
- Drammen,
- Gamle Fredrikstad,
- Hamar,
- Harstad,
- Haugesund,
- Horten,
- Jessheim,
- Kongsvinger,
- Kristiansand,
- Kristiansand,
- Lena,
- Levanger,
- Lillehammer,
- Mo I Rana,
- Oslo,
- Oslo,
- Oslo,
- Skien,
- Tiller,
- Tromsø,
- Trondheim,
- Ålesund,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information | |||||||
---|---|---|---|---|---|---|---|
Brief Title ICMJE | Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA | ||||||
Official Title ICMJE | A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE | ||||||
Brief Summary | The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response. | ||||||
Detailed Description | This multcenter, open-label, three period study will evaluate withdrawal and retreatment of etanercept in subjects with nr-ax SpA who achieved adequate response following 24 weeks of treatment. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Spondylitis, Ankylosing | ||||||
Intervention ICMJE | Biological: Etanercept
50 mg subcutaneous, once weekly, 24 weeks | ||||||
Study Arms ICMJE | Experimental: Etanercept
etanercept 50 mg QW Intervention: Biological: Etanercept | ||||||
Publications * | Not Provided | ||||||
* 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 | 210 | ||||||
Original Estimated Enrollment ICMJE | 200 | ||||||
Actual Study Completion Date ICMJE | September 6, 2019 | ||||||
Actual Primary Completion Date | May 28, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years to 49 Years (Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Belgium, Colombia, Czechia, Finland, France, Germany, Hungary, Netherlands, Poland, Spain, Sweden, Taiwan, United States | ||||||
Removed Location Countries | Czech Republic | ||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02509026 | ||||||
Other Study ID Numbers ICMJE | B1801381 2015-000541-24 ( EudraCT Number ) | ||||||
Has Data Monitoring Committee | No | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | June 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |