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Trial record 36 of 298 for:    "Ankylosing spondylitis"

Dose Reduction of Etanercept in Patients With Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT02638896
Recruitment Status : Unknown
Verified December 2015 by Zhixiang Huang, Health and Family Planning Commission of Guangdong.
Recruitment status was:  Not yet recruiting
First Posted : December 23, 2015
Last Update Posted : December 28, 2015
Sponsor:
Information provided by (Responsible Party):
Zhixiang Huang, Health and Family Planning Commission of Guangdong

Brief Summary:
The primary objective of this study is to evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in ankylosing spondylitis (AS) patients who have achieved a significant clinical response.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Drug: etanercept (Half-Dose) Drug: etanercept (Full-Dose) Drug: Sulfasalazine Drug: Celecoxib Phase 4

Detailed Description:
This single-centre, open-labeled randomized study will evaluate the efficacy of safety of etanercept dose reduction combined with sulfasalazine in patients who achieved a significant clinical response. AS patients who meet the inclusion criteria will take celecoxib (0.4g/d) during the whole period of study. In the first period, all patients will be given etanercept 50 mg subcutaneous injections weekly from baseline to week12. In the second period, patients who satisfied the criteria for disease remission will be randomized to one of the following three treatment arms: (1) Dose reduction arm: Patients will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. (2) Dose maintenance arm: Etanercept remains unchange from week12 to week24. (3) Etanercept discontinuation arm: Patients will be treated with sulfasalazine (2g/d) oral administration till week24. In the third period, all patients will take sulfasalazine (2g/d) till week 48. Ankylosing spondylitis disease activity score (ASDAS), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis functional index (BASFI), Bath ankylosing spondylitis metrology index (BASMI),Spondyloarthritis research consortium of Canada(SPARCC) score for the sacroiliac joint and adverse effect will be assessed in the study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Etanercept Dose Reduction in Patients With Ankylosing Spondylitis
Study Start Date : January 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : April 2017


Arm Intervention/treatment
Experimental: Dose reduction arm
AS patients who achieved remission will receive etanercept 50 mg subcutaneous injections every other weeks plus sulfasalazine (2g/d) oral administration till week24. Celecoxib will be the background therapy.
Drug: etanercept (Half-Dose)
AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will be randomized to one of the three treatment arms. In the dose reduction arm, patients will receive etanercept 50 mg subcutaneous injections every other weeks .
Other Name: Enbrel

Drug: Sulfasalazine
AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will take sulfasalazine (2g/d) from week12 to week48.
Other Name: Sulazine

Drug: Celecoxib
Celecoxib (0.4g/d) will be the background therapy.
Other Name: Celebrex

Active Comparator: Dose maintenance arm
AS patients who achieved remission will receive etanercept 50 mg subcutaneous injections every weeks plus sulfasalazine (2g/d) oral administration till week24. Celecoxib will be the background therapy.
Drug: etanercept (Full-Dose)
AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will be randomized to one of the three treatment arms. In the dose maintenance arm, patients will receive etanercept 50 mg subcutaneous injections every weeks.
Other Name: Enbrel

Drug: Sulfasalazine
AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will take sulfasalazine (2g/d) from week12 to week48.
Other Name: Sulazine

Drug: Celecoxib
Celecoxib (0.4g/d) will be the background therapy.
Other Name: Celebrex

Etanercept discontinuation arm
AS patients who achieved remission will take sulfasalazine (2g/d) till week24. Celecoxib will be the background therapy.
Drug: Sulfasalazine
AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will take sulfasalazine (2g/d) from week12 to week48.
Other Name: Sulazine

Drug: Celecoxib
Celecoxib (0.4g/d) will be the background therapy.
Other Name: Celebrex




Primary Outcome Measures :
  1. Change in ASDAS from baseline to week48. [ Time Frame: Baseline, Week12, Week24, Week48 ]
    ASDAS includes CRP (mg/L); Apart from the value of CRP, the four additional self-reported items (rated on 0-10 numerical rating scale [NRS]) included in this index are back pain, duration of morning stiffness, peripheral pain/swelling and patient global assessment of disease activity. The ASDAS scores are calculated as follows: ASDAS= (0.121×total back pain) + (0.110×subject global) + (0.073×peripheral pain/swelling) + (0.058×duration of morning stiffness) + (0.579×Ln(CRP+1)).


Secondary Outcome Measures :
  1. Change in ESR from baseline to week48. [ Time Frame: Baseline, Week12, Week24, Week48 ]
    ESR is a laboratory test that provides a non-specific measure of inflammation. This test assesses the rate at which red blood cells fall in a test tube and is measured in mm/h. Normal range is 0 to 30 mm/h. A higher rate is consistent with inflammation.

  2. Change in CRP from baseline to week48. [ Time Frame: Baseline, Week12, Week24, Week48 ]
    CRP is a marker of inflammation and measured in mg/L. A higher level is consistent with inflammation.

  3. Change in BASFI from baseline to Week48. [ Time Frame: Baseline, Week12, Week24, Week48 ]
    BASFI is a validated self assessment tool that determines the degree of functional limitation in AS patients. Participants answered 10 questions, consisting of 8 specific questions regarding function in AS patients and 2 questions reflecting the participant's ability to cope with everyday life. Each question was answered on a 0-10 scale (0 being no problem and 10 being the worst problem), the sum of which (divided by 10) resulted in the BASFI score (0-10).

  4. Change in BASMI from baseline to Week48. [ Time Frame: Baseline, Week12, Week24, Week48 ]
    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.

  5. Change in SPARCC score for the sacroiliac joint from baseline to Week48. [ Time Frame: Baseline, Week12, Week24, Week48 ]
    SPARCC score for the sacroiliac joint was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned a score of 0 = no lesion/1 = increased signal. For each slice, the score is increased by 1 for each joint that exhibits an intense signal in any quadrant. Also, for each slice, an additional score of 1 will be given for each joint that includes a lesion demonstrating continuous increased signal of a depth ≥1 cm from the articular surface. The maximum possible score is 72.

  6. Percentage of participants with serious adverse events (SAEs) or adverse events (AEs) by co-morbidity from baseline to Week48. [ Time Frame: Baseline, Week12, Week24, Week48 ]
    Any untoward medical occurrence in a participant who received study regents was considered an AE, without regard to possibility of relationship. An AE resulting in any of the following outcomes, or deemed to be significant for any other reason, was considered to be a SAE: death; initial or prolonged inpatient hospitalization; a life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients 18 to 45 years of age.
  2. Proven AS according to the modified New York criteria
  3. 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.
  4. Sexually active women of childbearing potential must agree and commit to use a medically accepted form of contraception.
  5. ASDAS score ≥2.1
  6. Ability to reconstitute the drug and self-inject it or have a person who can do so.
  7. Capability to understand and voluntarily give written informed consent that is signed and dated, before any specific procedure of the protocol is performed.
  8. Ability to store injectable test article at 2º to 8º C.

Exclusion Criteria:

  1. Pregnancy/lactation.
  2. Previously exposure to murine or chimeric monoclonal antibodies.
  3. Receipt of any live (attenuated) vaccines within 4 weeks before screening visit.
  4. History of chronic or a recent serious infection.
  5. History of tuberculosis within the last 3 years.
  6. History of malignancy.
  7. Significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection, central nervous system demyelinating events suggestive of multiple sclerosis.
  8. Presence or history of confirmed blood dyscrasias.
  9. History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening.
  10. Laboratory exclusions are: hemoglobin level < 8.5 mg/dl white blood cell count < 3.5×10e9/l, platelet count < 125 ×10e9/l, creatinine level > 175 mcmol/l, liver enzymes > 1.5 times the upper limit of normal or alkaline phosphatase > 2 times the upper limit of normal.
  11. Participation in trials of other investigational medications within 30 days of entering the study.
  12. Clinical examination showing significant abnormalities of clinical relevance.
  13. Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids.
  14. Hypersensitivity to any regent of study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02638896


Contacts
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Contact: Zhixiang Huang, MD 86-20-89169091 huang-zhix@163.com
Contact: Weiming Deng, MD 86-20-89169090 15088097855@163.com

Sponsors and Collaborators
Zhixiang Huang
Investigators
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Principal Investigator: Tianwang Li, MD Guangdong No.2 Provincial People's Hospital

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Responsible Party: Zhixiang Huang, MD, Health and Family Planning Commission of Guangdong
ClinicalTrials.gov Identifier: NCT02638896     History of Changes
Other Study ID Numbers: 2015117183344589
First Posted: December 23, 2015    Key Record Dates
Last Update Posted: December 28, 2015
Last Verified: December 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Zhixiang Huang, Health and Family Planning Commission of Guangdong:
Ankylosing Spondylitis
Etanercept
Sulfasalazine
Efficacy
Safety
dose
reduction

Additional relevant MeSH terms:
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Spondylitis
Spondylitis, Ankylosing
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Celecoxib
Etanercept
Sulfasalazine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors