Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis

Phase 2

• Conditions: Ankylosing Spondylitis
• Interventions: Biological: TNF alpha; Drug: NSAIDs and sulfasalazine

• Registration Number: NCT02456363
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2014-12-14
• Status Verified: 2015-05
• Study First Submitted QC: 2015-05-26
• Last Update Submitted: 2015-05-26
• Study First Posted: 2015-05-28
• Last Update Posted: 2015-05-28
• Primary Completion: 2019-10
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NSAIDs(-) and sulfasalazine(+)	NSAIDs and sulfasalazine	use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs
NSAIDs(+) and sulfasalazine(+)	NSAIDs and sulfasalazine	use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
NSAIDs(+) and sulfasalazine(-)	NSAIDs and sulfasalazine	use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
NSAIDs(+) and sulfasalazine(+)	TNF alpha	use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
NSAIDs(-) and sulfasalazine(-)	TNF alpha	use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) neither NSAIDs nor sulfasalazine
NSAIDs(+) and sulfasalazine(-)	TNF alpha	use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
NSAIDs(-) and sulfasalazine(+)	TNF alpha	use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs

Primary Outcome Measures

Name	Time	Method
mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)	weeks 92	weeks 92 of the spinal injury

Trial Locations

Locations (1)

Chung Shan Medical University Hospital; 🇨🇳 Taichung, Taiwan