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Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain

Last updated on January 24, 2020

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Ankylosing Spondylitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-70 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Diagnosis of ankylosing spondylitis, as defined by Modified New York Criteria for
Ankylosing Spondylitis.

2. Maintained inflammatory activity for more than 12 weeks defined by:·Axial forms:
BASDAI higher than or equal to 4 (0-10) and at least one of the following
parameters:. Global assessment of the disease by the patient higher than or equal to
4 (On a scale 0-10). Spinal pain higher than or equal to 4 on a visual analogue scale
(VAS). Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the
normality parameters established by the laboratory.·Peripheral forms: Arthritis or
enthesitis higher than or equal to 1 site and at least one of the following:. Global
assessment of the disease by the patient higher than or equal to 4 (on a scale 0-10).
Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the normality
parameters established by the laboratory

3. Failure to treatment: Failure to at least 2 NSAIDs at maximum recommended dose during
at least 3 months (or a shorter time in case of intolerance, toxicity or
contraindication).·In cases of ankylosing spondylitis with peripheral joint
involvement, salazopyrine should have been used at a dose of 2-3 g per day and/or
methotrexate (15 mg/week) for 4 months (or a shorter time in case of intolerance,
toxicity or contraindication). In case of oligoarticular or localized involvement in
enthesis: lack of response, at the discretion of the investigator, to local
infiltrations and/or synoviorthesis.

4. Be between 18-70 years of age

5. Negative result of a pregnancy test in serum in screening visit and in urine in
baseline visit, done in all women, except those surgically sterilized and those who
have at least one year of menopause.

6. Sexually active women of childbearing potential must use medically acceptable
contraceptive methods, including oral, injectable or implantable contraceptive
methods, intrauterine devices or properly used barrier contraception. A woman of
childbearing potential is defined as one who is biologically capable of becoming
pregnant. This includes women who are using contraceptives or whose sexual partners
are either sterile or using contraceptives.

7. Men who are not surgically sterile should agree to use reliable contraceptive methods
during the study.

8. Ability to reconstitute the drug and self-inject it or have a person who can do so.

9. Capability to understand and voluntarily give written informed consent that is signed
and dated, before any specific procedure of the protocol is performed.

10. Ability to store injectable test article at 2º to 8º C.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Contraindications for treatment with anti-TNF

2. Complete ankylosis of spine

3. Onset of treatment with DMARDs in the 4 weeks prior to baseline (SSZ, MTX and HCQ are
permitted if the administrated dose has been maintained stable in the 4 weeks prior
to baseline). Furthermore, patients with a dose of prednisone >10 mg/d or equivalent
or modified in the 2 weeks prior to the baseline visit, those in whose infiltration
has been performed with intraarticular corticosteroids has been performed in the 4
weeks prior to the screening visit and those who follow treatment with more than one
NSAID in the 2 weeks prior to the baseline visit are excluded.

4. Previous treatment with other TNF inhibitors and other biological drugs

5. Abnormalities in hematology profiles defined by:

- leukocytes lower than or equal to 3.5 x 10 exponent 9 /L

- hemoglobin lower than or equal to 8.5 g/L or 5.3 mmol/L

- hematocrit lower than or equal to 27%

- platelets lower than or equal to 125 x 10 exponent 9 /L

- serum creatinine higher than or equal to 175 mmol/L

- aspartate aminotransferase and alanine aminotransferase higher than or equal to
2 times the upper limit of normality

6. Important concomitant medical conditions, such as:-Class III or IV congestive heart
failure according to New York Heart Association classification-Uncontrolled arterial
hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening
diastolic blood pressure > 100 mm Hg)-Myocardial infarction within 12 months of the
screening visit or unstable angina-Severe pulmonary disease requiring hospitalization
or oxygen therapy-Diagnosis of multiple sclerosis or other central nervous system
demyelinating disease -Presence or history of confirmed blood dyscrasias-Cancer or
history of cancer (other than resected cutaneous basal cell or squamous cell
carcinoma)-Serious infection (infection requiring hospitalization and/or intravenous
antibiotics) within 1 month of administration of test article administration or
active infection at screening or history of recurrent or chronic infection-Open
cutaneous ulcers-Patients with known chronic infections as positivity to HIV,
hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) -Active tuberculosis
infection (local guidelines for appropriate screening and treatment of tuberculosis
in the setting of anti-TNF therapy must be followed)- Any condition that, in the
investigator's judgment, might cause this study to be detrimental to the subject

7. Pregnant or breast-feeding women

8. Past or current psychiatric illness that would interfere with the subject's ability
to comply with protocol requirements or give informed consent.

9. Treatment with any live (attenuated) vaccine within 4 weeks prior to baseline.

10. History of alcohol or drug abuse that would interfere with the subject's ability to
comply with protocol requirements.

11. Treatment with any investigational drug within 3 months of screening visit.

NCT00873730
Pfizer
Completed
Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain

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Descriptive Information
Brief Title  ICMJE Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain
Official Title  ICMJE A 12-week Randomized, Double-blind, Multicenter Pilot Study to Evaluate the Effect of Etanercept 100 mg and 50 mg Weekly in Subjects With Ankylosing Spondylitis
Brief Summary The purpose of this study was to evaluate efficacy and safety of etanercept 100 mg (50 mg twice a week) compared with 50 mg once a week in adult subjects with ankylosing spondylitis (AS) and previous failure to usual practice therapies in Spain.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Ankylosing Spondylitis
Intervention  ICMJE
  • Drug: etanercept
    Etanercept 50 mg twice a week (BIW) for 12 weeks
  • Drug: etanercept/placebo
    Etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: etanercept
  • Active Comparator: 2
    Intervention: Drug: etanercept/placebo
Publications * Navarro-Sarabia F, Fernández-Sueiro JL, Torre-Alonso JC, Gratacos J, Queiro R, Gonzalez C, Loza E, Linares L, Zarco P, Juanola X, Román-Ivorra J, Martín-Mola E, Sanmartí R, Mulero J, Diaz G, Armendáriz Y, Collantes E. High-dose etanercept in ankylosing spondylitis: results of a 12-week randomized, double blind, controlled multicentre study (LOADET study). Rheumatology (Oxford). 2011 Oct;50(10):1828-37. doi: 10.1093/rheumatology/ker083. Epub 2011 Jun 23.


*   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
 (submitted: June 30, 2009)
108
Original Actual Enrollment  ICMJE
 (submitted: April 1, 2009)
126
Actual Study Completion Date  ICMJE June 2008
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Diagnosis of ankylosing spondylitis, as defined by Modified New York Criteria for Ankylosing Spondylitis.
  2. Maintained inflammatory activity for more than 12 weeks defined by:·Axial forms: BASDAI higher than or equal to 4 (0-10) and at least one of the following parameters:. Global assessment of the disease by the patient higher than or equal to 4 (On a scale 0-10). Spinal pain higher than or equal to 4 on a visual analogue scale (VAS). Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the normality parameters established by the laboratory.·Peripheral forms: Arthritis or enthesitis higher than or equal to 1 site and at least one of the following:. Global assessment of the disease by the patient higher than or equal to 4 (on a scale 0-10). Increase in erythrocyte sedimentation rate (ESR) and/or CRP above the normality parameters established by the laboratory
  3. Failure to treatment: Failure to at least 2 NSAIDs at maximum recommended dose during at least 3 months (or a shorter time in case of intolerance, toxicity or contraindication).·In cases of ankylosing spondylitis with peripheral joint involvement, salazopyrine should have been used at a dose of 2-3 g per day and/or methotrexate (15 mg/week) for 4 months (or a shorter time in case of intolerance, toxicity or contraindication). In case of oligoarticular or localized involvement in enthesis: lack of response, at the discretion of the investigator, to local infiltrations and/or synoviorthesis.
  4. Be between 18-70 years of age
  5. Negative result of a pregnancy test in serum in screening visit and in urine in baseline visit, done in all women, except those surgically sterilized and those who have at least one year of menopause.
  6. Sexually active women of childbearing potential must use medically acceptable contraceptive methods, including oral, injectable or implantable contraceptive methods, intrauterine devices or properly used barrier contraception. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives.
  7. Men who are not surgically sterile should agree to use reliable contraceptive methods during the study.
  8. Ability to reconstitute the drug and self-inject it or have a person who can do so.
  9. Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
  10. Ability to store injectable test article at 2º to 8º C.

Exclusion criteria:

  1. Contraindications for treatment with anti-TNF
  2. Complete ankylosis of spine
  3. Onset of treatment with DMARDs in the 4 weeks prior to baseline (SSZ, MTX and HCQ are permitted if the administrated dose has been maintained stable in the 4 weeks prior to baseline). Furthermore, patients with a dose of prednisone >10 mg/d or equivalent or modified in the 2 weeks prior to the baseline visit, those in whose infiltration has been performed with intraarticular corticosteroids has been performed in the 4 weeks prior to the screening visit and those who follow treatment with more than one NSAID in the 2 weeks prior to the baseline visit are excluded.
  4. Previous treatment with other TNF inhibitors and other biological drugs
  5. Abnormalities in hematology profiles defined by:

    • leukocytes lower than or equal to 3.5 x 10 exponent 9 /L
    • hemoglobin lower than or equal to 8.5 g/L or 5.3 mmol/L
    • hematocrit lower than or equal to 27%
    • platelets lower than or equal to 125 x 10 exponent 9 /L
    • serum creatinine higher than or equal to 175 mmol/L
    • aspartate aminotransferase and alanine aminotransferase higher than or equal to 2 times the upper limit of normality
  6. Important concomitant medical conditions, such as:-Class III or IV congestive heart failure according to New York Heart Association classification-Uncontrolled arterial hypertension (defined as screening systolic blood pressure > 160 mm Hg or screening diastolic blood pressure > 100 mm Hg)-Myocardial infarction within 12 months of the screening visit or unstable angina-Severe pulmonary disease requiring hospitalization or oxygen therapy-Diagnosis of multiple sclerosis or other central nervous system demyelinating disease -Presence or history of confirmed blood dyscrasias-Cancer or history of cancer (other than resected cutaneous basal cell or squamous cell carcinoma)-Serious infection (infection requiring hospitalization and/or intravenous antibiotics) within 1 month of administration of test article administration or active infection at screening or history of recurrent or chronic infection-Open cutaneous ulcers-Patients with known chronic infections as positivity to HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) -Active tuberculosis infection (local guidelines for appropriate screening and treatment of tuberculosis in the setting of anti-TNF therapy must be followed)- Any condition that, in the investigator's judgment, might cause this study to be detrimental to the subject
  7. Pregnant or breast-feeding women
  8. Past or current psychiatric illness that would interfere with the subject's ability to comply with protocol requirements or give informed consent.
  9. Treatment with any live (attenuated) vaccine within 4 weeks prior to baseline.
  10. History of alcohol or drug abuse that would interfere with the subject's ability to comply with protocol requirements.
  11. Treatment with any investigational drug within 3 months of screening visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00873730
Other Study ID Numbers  ICMJE 0881A3-406
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date April 2010

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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

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[email protected]

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