Clinical trial NCT02456363: Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis
Official title: Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis-A Registry Project
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Ankylosing Spondylitis
Keywords: Adalimumab
NSAIDs
safety
efficacy
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)

Eligibility 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

Primary outcomes:
measure: mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)
timeFrame: weeks 92
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Chung Shan Medical University Hospital
Study officials:
affiliation: Chung Shan Medical University
name: Wei C- C, M.D.
role: STUDY_DIRECTOR
References: