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Trial record 33 of 372 for:    Ankylosing Spondylitis

Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis

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ClinicalTrials.gov Identifier: NCT02456363
Recruitment Status : Recruiting
First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):
GCRC, Chung Shan Medical University

Brief Summary:
Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment of ankylosing spondylitis patient safety and efficacy.

Condition or disease Intervention/treatment Phase
Ankylosing Spondylitis Biological: TNF alpha Drug: NSAIDs and sulfasalazine Phase 2

Detailed Description:

In this study, single center, treatment, open, randomized, controlled clinical trial to assess Adalimumab(Humira) style with NSAIDs for the treatment of patients with ankylosing spondylitis, a total of 300 are expected to be included in the consent form signed by the subject, will be randomly assigned to treatment groups with a control group of 150 people.

Subjects to be returned in the first week outpatient follow 0,8,20,44,68,92 accept routine physical examination (weight, blood pressure, etc.), AS Scale (BASDAI, BASFI, BAS-G), fingertip ground tests, lumbar range of motion, chest expansion test, lateral bending test, the occipital bone measurements, physician global assessment (Physician global assessment), patient pain scores (VAS), AS quality of Life scale (ASQOL), SF-36 quality of life scale, Complete joint assessment, ASAS20 response criteria, assessment of laboratory analysis inflammation index (HS-CRP, IgA, ESR), safety index checks (CBC, SGPT, Serum creatinine, HBV-DNA if HbsAg (+), HCV -RNA if HCVAB.

Subjects need to return OPD week 0, accept Anti-HBs, Anti-HBc, HBsAg, Anti-HCV. Subjects required to return to the first outpatient follow 0,20,92 weeks, pulmonary function tests.

Therefore, the subjects in the 92 weeks of the trial, a total need for blood six times, each time for blood about 10 cc. And to assess side effects and adverse events (Adverse Event, AE), serious adverse events (Serious Adverse Event, SAE)


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis—A Registry Project
Study Start Date : November 2009
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: NSAIDs(+) and sulfasalazine(+)
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
Biological: TNF alpha
Depending on patient need to use different TNF alpha
Other Names:
  • Drug: Adalimumab (Humira)
  • Drug: Etanercept (Enbrel)
  • Drug: Golimumab (Simponi)

Drug: NSAIDs and sulfasalazine
randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
Other Names:
  • Drug: Arcoxia
  • Drug: Celebrex
  • Drug: Tonec
  • Drug: Mobic
  • Drug: sulfasalazine

Experimental: NSAIDs(+) and sulfasalazine(-)
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
Biological: TNF alpha
Depending on patient need to use different TNF alpha
Other Names:
  • Drug: Adalimumab (Humira)
  • Drug: Etanercept (Enbrel)
  • Drug: Golimumab (Simponi)

Drug: NSAIDs and sulfasalazine
randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
Other Names:
  • Drug: Arcoxia
  • Drug: Celebrex
  • Drug: Tonec
  • Drug: Mobic
  • Drug: sulfasalazine

Experimental: NSAIDs(-) and sulfasalazine(+)
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs
Biological: TNF alpha
Depending on patient need to use different TNF alpha
Other Names:
  • Drug: Adalimumab (Humira)
  • Drug: Etanercept (Enbrel)
  • Drug: Golimumab (Simponi)

Drug: NSAIDs and sulfasalazine
randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
Other Names:
  • Drug: Arcoxia
  • Drug: Celebrex
  • Drug: Tonec
  • Drug: Mobic
  • Drug: sulfasalazine

Experimental: NSAIDs(-) and sulfasalazine(-)
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) neither NSAIDs nor sulfasalazine
Biological: TNF alpha
Depending on patient need to use different TNF alpha
Other Names:
  • Drug: Adalimumab (Humira)
  • Drug: Etanercept (Enbrel)
  • Drug: Golimumab (Simponi)




Primary Outcome Measures :
  1. mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score) [ Time Frame: weeks 92 ]
    weeks 92 of the spinal injury



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age ≥18 years old
  • HLA B27 positive
  • X ray examination
  • Clinical symptoms and physical examination, the following three conditions are subject to at least two:

    i.lower back pain and morning stiffness symptoms persist more than 3 months ii. lumbar activity is restricted iii. chest expansion is restricted

  • Active disease for four weeks or more (continue two examination BASDAI>6, ESR> 28 mm/1 hr and CRP>1 mg/dl)

Exclusion Criteria:

  • pregnant or breast-feeding women
  • patients with active infections
  • highly infectious patients
  • Cancer or precancerous condition of the patient
  • multiple sclerosis

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): NCT02456363


Locations
Taiwan
Chung Shan Medical University Hospital Recruiting
Taichung, Taiwan
Contact: Cheng-Chung Wei, M.D., Ph.D.    24739595 ext 34718    wei3228@gmail.com   
Sponsors and Collaborators
Chung Shan Medical University
Investigators
Study Director: Wei C- C, M.D. Chung Shan Medical University

Responsible Party: GCRC, Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine, Chung Shan Medical University
ClinicalTrials.gov Identifier: NCT02456363     History of Changes
Other Study ID Numbers: CS09128
First Posted: May 28, 2015    Key Record Dates
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by GCRC, Chung Shan Medical University:
Adalimumab
NSAIDs
safety
efficacy

Additional relevant MeSH terms:
Spondylitis
Spondylitis, Ankylosing
Necrosis
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Pathologic Processes
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis
Adalimumab
Etanercept
Sulfasalazine
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Immunosuppressive Agents
Immunologic Factors
Anti-Infective Agents