Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis

Chung Shan Medical University

Status and phase: Unknown; Phase 2

Conditions: Ankylosing Spondylitis

Treatments: Drug: NSAIDs and sulfasalazine; Biological: TNF alpha

Study type: Interventional

Funder types: Other

Identifiers

NCT02456363

CS09128

Details and patient eligibility

About

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

Full 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)

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 4 patient groups

NSAIDs(+) and sulfasalazine(+)

Experimental group

Description:

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine

Treatment:

Biological: TNF alpha

Drug: NSAIDs and sulfasalazine

NSAIDs(+) and sulfasalazine(-)

Experimental group

Description:

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine

Treatment:

Biological: TNF alpha

Drug: NSAIDs and sulfasalazine

NSAIDs(-) and sulfasalazine(+)

Experimental group

Description:

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs

Treatment:

Biological: TNF alpha

Drug: NSAIDs and sulfasalazine

NSAIDs(-) and sulfasalazine(-)

Experimental group

Description:

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) neither NSAIDs nor sulfasalazine

Treatment:

Biological: TNF alpha