Ankylosing SpondylitisPhase 2NCT02456363
Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis
A Phase 2 study testing TNF alpha and NSAIDs and sulfasalazine in people with Ankylosing Spondylitis, run by Chung Shan Medical University at 1 site in Taiwan.
Trial summary
Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment of ankylosing spondylitis patient safety and efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- TNF alpha and NSAIDs and sulfasalazine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2009to Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- pregnant or breast-feeding women
- patients with active infections
- highly infectious patients
- Cancer or precancerous condition of the patient
- multiple sclerosis
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Chung Shan Medical University Hospital
Taichung
Cheng-Chung Wei, M.D., Ph.D., 24739595 ext. 34718, wei3228@gmail.com
About this study
Official title: 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.
Read the 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
- Being tested
- TNF alpha, NSAIDs and sulfasalazine
- Keywords
- Adalimumab, NSAIDs, safety, efficacy
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TNF alphaBiological
Also called Drug: Adalimumab (Humira), Drug: Etanercept (Enbrel), Drug: Golimumab (Simponi)
Depending on patient need to use different TNF alpha
NSAIDs and sulfasalazineDrug
Also called Drug: Arcoxia, Drug: Celebrex, Drug: Tonec, Drug: Mobic
randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
| Study group | Role | What they receive |
|---|---|---|
| NSAIDs(+) and sulfasalazine(+) | Experimental | use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine Receives: Biological: TNF alpha; Drug: NSAIDs and sulfasalazine |
| NSAIDs(+) and sulfasalazine(-) | Experimental | use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine Receives: Biological: TNF alpha; Drug: NSAIDs and sulfasalazine |
| NSAIDs(-) and sulfasalazine(+) | Experimental | use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs Receives: Biological: TNF alpha; Drug: NSAIDs and sulfasalazine |
| NSAIDs(-) and sulfasalazine(-) | Experimental | use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) neither NSAIDs nor sulfasalazine Receives: Biological: TNF alpha |
What is being measured
The primary outcome is the main question the study is designed to answer.
mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)
weeks 92 of the spinal injury
Measured: weeks 92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startNov 2009
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chung Shan Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GCRC, Chung Shan Medical University
- Investigators
- Wei C- C, M.D., Study director, Chung Shan Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456363
- Sponsor's protocol ID
- CS09128
- Status last verified
- May 2015
- First submitted
- 14 Dec 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Tumor Necrosis Factor Therapy In Patients With Ankylosing Spondylitis-A Registry Project
- ClinicalTrials.gov ID
- NCT02456363
- Acronym / sponsor ID
- CS09128
- Conditions
- Ankylosing Spondylitis
- Keywords
- Adalimumab, NSAIDs, safety, efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Chung Shan Medical UniversityUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| NSAIDs(+) and sulfasalazine(+) | Experimental | Biological: TNF alpha, Drug: NSAIDs and sulfasalazineuse TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine |
| NSAIDs(+) and sulfasalazine(-) | Experimental | Biological: TNF alpha, Drug: NSAIDs and sulfasalazineuse TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine |
| NSAIDs(-) and sulfasalazine(+) | Experimental | Biological: TNF alpha, Drug: NSAIDs and sulfasalazineuse TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs |
| NSAIDs(-) and sulfasalazine(-) | Experimental | Biological: TNF alphause TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) neither NSAIDs nor sulfasalazine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- pregnant or breast-feeding women
- patients with active infections
- highly infectious patients
- Cancer or precancerous condition of the patient
- multiple sclerosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TNF alphaAlso: Drug: Adalimumab (Humira), Drug: Etanercept (Enbrel), Drug: Golimumab (Simponi)Depending on patient need to use different TNF alpha | Biological | NSAIDs(+) and sulfasalazine(+), NSAIDs(+) and sulfasalazine(-), NSAIDs(-) and sulfasalazine(+), NSAIDs(-) and sulfasalazine(-) |
| NSAIDs and sulfasalazineAlso: Drug: Arcoxia, Drug: Celebrex, Drug: Tonec, Drug: Mobicrandomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+) | Drug | NSAIDs(+) and sulfasalazine(+), NSAIDs(+) and sulfasalazine(-), NSAIDs(-) and sulfasalazine(+) |
Primary outcome
mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)
Time frame: weeks 92
weeks 92 of the spinal injury
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei C- C, M.D. study director
Chung Shan Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TNF alpha and NSAIDs and sulfasalazine in people with Ankylosing Spondylitis, run by Chung Shan Medical University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score) (time frame: weeks 92). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2015.