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Study Evaluating Etanercept in Subjects With Ankylosing Spondylitis in Spain (Loadet)

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ClinicalTrials.gov Identifier: NCT00873730
Recruitment Status : Completed
First Posted : April 2, 2009
Results First Posted : August 13, 2009
Last Update Posted : April 28, 2010
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 2, 2009
Results First Submitted Date  ICMJE June 30, 2009
Results First Posted Date  ICMJE August 13, 2009
Last Update Posted Date April 28, 2010
Study Start Date  ICMJE December 2006
Actual Primary Completion Date June 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 20. [ Time Frame: 12 weeks ]
ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 20 = 20% improvement (vs. baseline) and an absolute change ≥ 10 units on a 0-100 scale (0=no disease activity; 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
Original Primary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
Proportion of subjects who reach 20% improvement in assessment of ankylosing spondylitis (ASAS) in week 12. ASAS response criteria include measurement of pain, function, inflammation and global assessment by patient of disease activity. [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
  • Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 40. [ Time Frame: 12 weeks ]
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 40 = 40% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
  • Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 50. [ Time Frame: 12 weeks ]
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 50 = 50% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
  • Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 70. [ Time Frame: 12 weeks ]
    ASAS measures symptomatic improvement in Ankylosing Spondylitis (AS) patients. ASAS = 4 domains: patient global assessment of disease activity, pain, function, inflammation. ASAS 70 = 70% improvement (vs. baseline) and an absolute change ≥ 20 units on a 0-100 scale (0=no disease activity, 100=high disease activity) for ≥ 3 domains, and no worsening in remaining domain.
  • Number of Patients Achieving Assessment in Ankylosing Spondylitis (ASAS) 5/6. [ Time Frame: 12 weeks ]
    ASAS 5/6 consists of 6 domains: the 4 used in ASAS 20 (patient global assessment of disease activity, pain, function, inflammation measured on a 0-100 scale, where 0=no disease activity, 100=high disease activity) plus spinal mobility and an acute phase reactant, C Reactive Protein (CRP). Achieving ASAS 5/6 requires a 20% improvement compared to baseline in ≥ 5 domains and no worsening in the remaining domain.
  • Number of Patients Achieving Partial Remission. [ Time Frame: 12 weeks ]
    Partial remission defined as a score of less than 20 units (on a scale of 0-100, where 0=no disease activity, 100=high disease activity) in each of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains: patient global assessment of disease activity, pain, function, and inflammation. For scale, 100=high disease activity.
  • Change in Nocturnal Back and Overall Spinal Pain From Baseline to Week 12. [ Time Frame: Baseline and 12 weeks ]
    Nocturnal back and overall spinal pain assessed by patients using a Visual Analog Scale (VAS) of 0 - 10 (0 = no pain and 10 = most severe pain).
  • Change in Physician and Patient Global Assessment (PGA) of Pain From Baseline to Week 12. [ Time Frame: Baseline and 12 weeks ]
    Patient pain assessed by physician and patient using a Visual Analog Scale (VAS) of 0 - 10 (0 = none and 10 = severe).
  • Change in Bath Ankylosing Spondylitis Functional Index (BASFI) From Baseline to Week 12. [ Time Frame: Baseline and 12 weeks ]
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Utilizing a VAS of 0-10 (0=easy, 10=impossible), patients answered 10 questions assessing their ability in completing normal daily activities or physically demanding activities. The BASFI score is a mean score of the 10 questions.
  • Change in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) From Baseline to Week 12. [ Time Frame: Baseline and 12 weeks ]
    BASDAI is a validated self assessment tool used to determine disease activity in patients with Ankylosing Spondylitis (AS). Utilizing a Visual Analog Scale (VAS) of 0-10 (0=none and 10=very severe) patient's answered 6 questions measuring discomfort, pain and fatigue. The BASDAI final mean score was calculated taking all 6 VAS assessments.
  • Change in Bath Ankylosing Spondylitis Metrology Index (BASMI) From Baseline to Week 12. [ Time Frame: Baseline and 12 weeks ]
    BASMI is an objective measure of spinal mobility. The BASMI score is composed of 5 measures: cervical rotation, intermalleolar distance, modified Schober's test, lateral flexion and tragus to wall distance. Each measure was scored 0-2 (0=normal mobility, 2=severe reduction) to give a final score ranging 0 to 10.
  • Change in Erythrocyte Sedimentation Rate (ESR) From Baseline to Week 12. [ Time Frame: Baseline and 12 weeks ]
    ESR is a laboratory test that provides a non-specific measure of inflammation. The test assesses the rate at which red blood cells fall in a test tube and is measured in mm/hour. Normal range is 0-30mm/h. A higher rate is consistent with inflammation.
  • Ankylosing Spondylitis Quality of Life (EuroQoL) Questionnaire [ Time Frame: 12 weeks ]
    EuroQol questionnaire is intended to measure the quality of life by means of questions about mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Answers to every question were grouped in two main categories: with problems (having some problems or absolutely unable) or without problems.
  • Change in 36-Item Short-Form Health Survey (SF-36) From Baseline to Week 12. [ Time Frame: Baseline and 12 weeks ]
    SF-36 is a standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health. The score for a section is an average of the individual question scores, which are scaled 0-100 (100=highest level of functioning).
  • Improvement of Ocular Inflammatory Disease in Patients With Baseline Symptoms [ Time Frame: 12 weeks ]
  • Change in C-reactive Protein (CRP) From Baseline to Week 12. [ Time Frame: Baseline and 12 weeks ]
    CRP is a marker of inflammation and measured in mg/l. A higher level is consistent with inflammation.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 1, 2009)
ASAS40, ASAS50, ASAS70, ASAS5/6 week 12 response; partial remission; nocturnal and overall spinal pain, PGA, BASFI, BASDAI, BASMI, PCR-VSG, EuroQoL, SF-36 and Improvement of ocular inflammatory disease in patients with baseline symptoms [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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