Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis

Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis-A Registry Project

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02456363

Enrollment

300

Registered

2015-05-28

Start date

2009-11-30

Completion date

2019-12-31

Last updated

2015-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankylosing Spondylitis

Keywords

Adalimumab, NSAIDs, safety, efficacy

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)

Interventions

BIOLOGICALTNF alpha

Depending on patient need to use different TNF alpha

DRUGNSAIDs and sulfasalazine

randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)	weeks 92	weeks 92 of the spinal injury

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026