A Phase 2 interventional study of TNF alpha and NSAIDs and sulfasalazine in Ankylosing Spondylitis, sponsored by Chung Shan Medical University. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-28.
Sponsored by Chung Shan Medical University · Phase 2, Interventional, and Treatment
Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment of ankylosing spondylitis patient safety and efficacy.
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)
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's planned enrollment of 300 is above the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Chung Shan Medical University is the lead sponsor of 124 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
Biological: TNF alpha · Drug: NSAIDs and sulfasalazine
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
Biological: TNF alpha · Drug: NSAIDs and sulfasalazine
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs
Biological: TNF alpha · Drug: 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
Also known as: Drug: Adalimumab (Humira), Drug: Etanercept (Enbrel), Drug: Golimumab (Simponi)
randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
Also known as: Drug: Arcoxia, Drug: Celebrex, Drug: Tonec, Drug: Mobic, Drug: sulfasalazine
mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)
weeks 92 of the spinal injury
Time frame: weeks 92
This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.
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Chung Shan Medical University