Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis

May 26, 2015 updated by: GCRC, Chung Shan Medical University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taichung, Taiwan
        • Recruiting
        • Chung Shan Medical University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NSAIDs(+) and sulfasalazine(+)
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
Biological: TNF alpha
Depending on patient need to use different TNF alpha
Other Names:
  • Drug: Adalimumab (Humira)
  • Drug: Etanercept (Enbrel)
  • Drug: Golimumab (Simponi)
Drug: NSAIDs and sulfasalazine
randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
Other Names:
  • Drug: Arcoxia
  • Drug: Celebrex
  • Drug: Tonec
  • Drug: Mobic
  • Drug: sulfasalazine
Experimental: NSAIDs(+) and sulfasalazine(-)
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine
Biological: TNF alpha
Depending on patient need to use different TNF alpha
Other Names:
  • Drug: Adalimumab (Humira)
  • Drug: Etanercept (Enbrel)
  • Drug: Golimumab (Simponi)
Drug: NSAIDs and sulfasalazine
randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
Other Names:
  • Drug: Arcoxia
  • Drug: Celebrex
  • Drug: Tonec
  • Drug: Mobic
  • Drug: sulfasalazine
Experimental: NSAIDs(-) and sulfasalazine(+)
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs
Biological: TNF alpha
Depending on patient need to use different TNF alpha
Other Names:
  • Drug: Adalimumab (Humira)
  • Drug: Etanercept (Enbrel)
  • Drug: Golimumab (Simponi)
Drug: NSAIDs and sulfasalazine
randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
Other Names:
  • Drug: Arcoxia
  • Drug: Celebrex
  • Drug: Tonec
  • Drug: Mobic
  • Drug: sulfasalazine
Experimental: NSAIDs(-) and sulfasalazine(-)
use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) neither NSAIDs nor sulfasalazine
Biological: TNF alpha
Depending on patient need to use different TNF alpha
Other Names:
  • Drug: Adalimumab (Humira)
  • Drug: Etanercept (Enbrel)
  • Drug: Golimumab (Simponi)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chung Shan Medical University

Investigators

  • Study Director: Wei C- C, M.D., Chung Shan Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Anticipated)

October 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

December 14, 2014

First Submitted That Met QC Criteria

May 26, 2015

First Posted (Estimate)

May 28, 2015

Study Record Updates

Last Update Posted (Estimate)

May 28, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS09128

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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