Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis

NCT ID: NCT02456363

Last Updated: 2015-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2019-12-31

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)

Conditions

Ankylosing Spondylitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NSAIDs(+) and sulfasalazine(+)

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

Group Type: EXPERIMENTAL

TNF alpha

Intervention Type: BIOLOGICAL

Depending on patient need to use different TNF alpha

NSAIDs and sulfasalazine

Intervention Type: DRUG

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

NSAIDs(+) and sulfasalazine(-)

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

Group Type: EXPERIMENTAL

TNF alpha

Intervention Type: BIOLOGICAL

Depending on patient need to use different TNF alpha

NSAIDs and sulfasalazine

Intervention Type: DRUG

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

NSAIDs(-) and sulfasalazine(+)

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

Group Type: EXPERIMENTAL

TNF alpha

Intervention Type: BIOLOGICAL

Depending on patient need to use different TNF alpha

NSAIDs and sulfasalazine

Intervention Type: DRUG

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

NSAIDs(-) and sulfasalazine(-)

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

Group Type: EXPERIMENTAL

TNF alpha

Intervention Type: BIOLOGICAL

Depending on patient need to use different TNF alpha

Interventions

TNF alpha

Depending on patient need to use different TNF alpha

Intervention Type: BIOLOGICAL

NSAIDs and sulfasalazine

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

Intervention Type: DRUG

Other Intervention Names

Drug: Adalimumab (Humira); Drug: Etanercept (Enbrel); Drug: Golimumab (Simponi); Drug: Arcoxia; Drug: Celebrex; Drug: Tonec; Drug: Mobic; Drug: sulfasalazine

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chung Shan Medical University

OTHER

Sponsor Role: lead

Responsible Party

GCRC

Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wei C- C, M.D.

Role: STUDY_DIRECTOR

Chung Shan Medical University

Locations

Chung Shan Medical University Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Cheng-Chung Wei, M.D., Ph.D.

Role: primary

wei3228@gmail.com

24739595 ext. 34718

Other Identifiers

CS09128

Identifier Type: -

Identifier Source: org_study_id