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Ankylosing SpondylitisPhase 2TOPASNCT01330901

Ustekinumab for the Treatment of Patients With Active Ankylosing Spondylitis

A Phase 2 study testing Ustekinumab in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study is aimed at investigation of efficacy and safety of ustekinumab (monoclonal antibody against interleukin 12 and 23) treatment in patients with active ankylosing spondylitis (AS) fulfilling the modified New York criteria who have had an inadequate response to standard therapy with non-steroidal… 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?
Ustekinumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteGermany
Study dates
Oct 2011to May 2013
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 of ≥18 years.
  • Definite diagnosis of AS according to the modified New York criteria.
  • History of an inadequate response to ≥2 NSAIDs taken for at least 2 weeks each or NSAIDs intolerance/contraindication.
  • Active disease as defined by a BASDAI value of ≥4 at screening despite concomitant treatment with an NSAID or without NSAIDs in case of intolerance/contraindication.
  • Able and willing to give a written informed consent and comply with the requirements of the study protocol.
  • If female: either not of child-bearing potential (menopausal since 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception.
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  • If male: either not of child-bearing potential (surgically sterilized, e.g. vasectomy) or is willing and able to practice a reliable method of contraception.
  • If on NSAIDs: the dose must be stable for at least 2 weeks prior to baseline.
  • If on oral steroids: the dose must not exceed 10 mg (prednisolone equivalent) per day and must be stable for at least 4 weeks prior to baseline.
  • If on methotrexate: the dose must not exceed 25 mg per week and must be stable for at least 4 weeks prior to baseline, must be stable for 4 weeks prior to baseline.
  • If on analgesics: the dose must be stable for at least 2 weeks prior to baseline.

Who cannot join

  • The female subject is pregnant or lactating.
  • Patients with other chronic inflammatory articular disease or systemic autoimmune disease.
  • History of inadequate response to previous anti-tumor necrosis factor (TNF) α therapy.
  • Previous treatment with biologics other than TNF α blockers.
  • Treatment with any other investigational drug within 4 weeks of 5 half-life of the drug (whichever is longer) prior to baseline.
  • Treatments with disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate within 4 weeks prior to screening (8 weeks for leflunomide or 4 weeks with a standard cholestyramine wash-out).
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  • Treatment with intravenous, intramuscular or intraarticular/periarticular steroids within 4 weeks prior to screening.
  • Any active current infection, a history of recurrent clinically significant infection, infections requiring treatment with antibiotics within 4 weeks prior to baseline.
  • Current clinical signs and symptoms suggestive for tuberculosis.
  • Positive interferon gamma release assay (IGRA) test at screening and/or abnormal chest x-ray (performed at screening or within 3 months prior to screening) suggestive for past or present tuberculosis (positive x-ray). Patients with a positive IGRA test but negative chest x-ray and without clinical symptoms suggestive for tuberculosis may participate in the study after initiation of standard prophylactic antimycobacterial treatment.
  • Chronic infection with hepatitis B or C, history of human immunodeficiency virus infection.
  • Primary or secondary immunodeficiency.
  • Actual malignancies or history of malignancies with curative treatment within 5 years prior to screening, except successfully treated non-metastatic squamous-cell or basal-cell carcinoma or carcinoma in situ of the cervix.
  • Evidence of severe uncontrolled gastrointestinal, hepatic, renal, pulmonary, cardiovascular, nervous or endocrine disorders.
  • Any other conditions making the patient unsuitable in the opinion of the investigator for the participation in the current study.
  • Patients with a history of a severe psychiatric illness, which might interfere with the patient's ability to understand the requirements of the study and assessment.
  • Diagnosis of fibromyalgia.
  • Alcohol abuse or illegal drug consume in the last 12 months.
  • Vaccination with a live vaccine within 12 weeks prior to baseline.
  • Known hypersensitivity to any component of the study medication.
  • Clinically significant laboratory abnormalities
  • Patients who are institutionalised due to regulatory or juridical order.
  • Patients with contraindications for the magnetic resonance imaging (MRI)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Department of Rheumatology, Charité - Campus Benjamin Franklin

    Berlin, 12203

Other trials in Germany

About this study

Official title: UsTekinumab for the Treatment Of Patients With Active Ankylosing Spondylitis (TOPAS) - a 28-week, Prospective, Open-label, Proof-of-concept Study

This study is aimed at investigation of efficacy and safety of ustekinumab (monoclonal antibody against interleukin 12 and 23) treatment in patients with active ankylosing spondylitis (AS) fulfilling the modified New York criteria who have had an inadequate response to standard therapy with non-steroidal anti-inflammatory drugs (NSAIDs) or do not tolerate or have a contraindication for NSAIDs.

Read the detailed description

This study is a prospective, open-label, proof-of-concept clinical trial that will be conducted in a referral center for patients with AS in Berlin. Eligible patients will be treated with ustekinumab 90 mg given subcutaneously at weeks 0, 4, and 16. The entire study period accounts 28 weeks. Assessment of the primary outcome parameter will be performed at week 24. The patients will be closely monitored throughout the study on a total of 9 visits.

Being tested
Ustekinumab
Medical subject headings
Spondylitis, Ankylosing

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UstekinumabDrug

    Also called Stelara

    Ustekinumab 90 mg given subcutaneously at weeks 0, 4, and 16

Study groups in NCT01330901
Study groupRoleWhat they receive
UstekinumabExperimentalUstekinumab 90 mg subcutaneously at week 0, 4 and 16
Receives: Drug: Ustekinumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Assessment of Spondyloarthritis International Society (ASAS)40 response

    The percentage of patients who achieved ASAS40 response defined as an improvement of ≥40% and ≥2 points in at least 3 out of four following domains (and no worsening in remaining domain):

    • Patient global
    • Pain
    • Function (as measured by the Bath Ankylosing Spondylitis Functional Index - BASFI)
    • Inflammation (mean of the Bath Ankylosing Spondylitis Disease Activity Index - BASDAI question 5 and 6)

    Measured: week 24

Secondary outcomes (5)

  1. The Assessment of Spondyloarthritis International Society (ASAS)20 response at week 24

    The percentage of patients who achieved ASAS20 response defined as an improvement of ≥20% and ≥1 points in at least 3 out of four following domains (and no worsening of ≥20% and ≥1 points in remaining domain):

    • Patient global
    • Pain
    • Function (as measured by the Bath Ankylosing Spondylitis Functional Index - BASFI)
    • Inflammation (mean of the Bath Ankylosing Spondylitis Disease Activity Index - BASDAI question 5 and 6)

    Measured: Week 24

  2. The Ankylosing Spondylitis Disease Activity Score (ASDAS) clinically important improvement

    The percentage of patients who achieved the ASDAS clinically important improvement (≥1.1) at week 24

    Measured: Week 24

  3. The Assessment of Spondyloarthritis International Society (ASAS) partial remission

    The percentage of patients who achieved partial remission according to the ASAS definition at week 24

    Measured: Week 24

  4. The Ankylosing Spondylitis Disease Activity Score (ASDAS) major improvement

    The percentage of patients who achieved the ASDAS major improvement (≥2.0) at week 24

    Measured: Week 24

  5. Number of participants with adverse events as a measure of safety and tolerability

    Number of participants with adverse events as a measure of safety and tolerability up to week 28

    Measured: Week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2011 (estimated)
  2. Study startOct 2011
  3. Primary completionApr 2013
  4. Study completionMay 2013

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01330901
Sponsor's protocol ID
TOPAS
Acronym
TOPAS
Status last verified
Jun 2013
First submitted
5 Apr 2011
Last updated
4 Jun 2013
Results posted
No
Data monitoring committee
No

Publications

  • Parthasarathy R, Santiago F, McCluskey P, Kaakoush NO, Tedla N, Wakefield D. The microbiome in HLA-B27-associated disease: implications for acute anterior uveitis and recommendations for future studies. Trends Microbiol. 2023 Feb;31(2):142-158. doi: 10.1016/j.tim.2022.08.008. Epub 2022 Sep 1.

    PubMed 36058784

  • Poddubnyy D, Hermann KG, Callhoff J, Listing J, Sieper J. Ustekinumab for the treatment of patients with active ankylosing spondylitis: results of a 28-week, prospective, open-label, proof-of-concept study (TOPAS). Ann Rheum Dis. 2014 May;73(5):817-23. doi: 10.1136/annrheumdis-2013-204248. Epub 2014 Jan 3.

    PubMed 24389297

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ustekinumab in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 1 site in Germany.

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 11 inclusion and 23 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: finished, as of the sponsor's last update on 4 Jun 2013. 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 Germany. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Assessment of Spondyloarthritis International Society (ASAS)40 response (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01330901, which also lists 2 linked publications.

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 4 Jun 2013.

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