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Ankylosing SpondylitisPhase 2Enbrel_AS-2NCT01289743

Etanercept (Enbrel) in Ankylosing Spondylitis

A Phase 2 study testing Etanercept in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The study has the aim to investigate the efficacy and safety of etanercept in patients with active ankylosing spondylitis (AS) over 520 weeks. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Ankylosing Spondylitis
What is being tested?
Etanercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesGermany
Study dates
Feb 2002to May 2012
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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients 18 to 65 years of age.
  • Proven ankylosing spondylitis according to the modified New York criteria
  • Acute phase of disease with high disease activity the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 or a pain score ≥ 4 on a Numeric Rating Scale (NRS) at two occasions in 2 weeks
  • Understand, sign. and date the written informed consent at the screening visit.
  • Sexually active women participatittg in the study must use a medically acceptable form of contraception until 6 month after the last injection of study medication. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy.
  • Sexually active men must agree to use a medically accepted form of contraception during the study until 6 month after the last injection of study medication.
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  • Negative serum or urine pregnancy test taken at screen in all women except those surgically sterile or at least 1 year postmenopausal.
  • Able to self-administer injectable drug supplies or have a caregiver who will do so.
  • Able to store injectable test article at 2° to 8° C.

Who cannot join

  • Pregnancy/lactation
  • Previously exposure to murine or chimeric monoclonal antibodies
  • Receipt of any live (attenuated) vaccines within 4 weeks before screening visit
  • History of chronic or a recent serious infection
  • History of tuberculosis within the last 3 years
  • History of malignancy
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  • Significant concurrent medical diseases including uncompensated congestive heart failure, myocardial infarction within 12 months, stable or unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease, history of human immunodeficiency virus (HIV) infection, central nervous system demyelinating events suggestive of multiple sclerosis
  • Presence or history of confirmed blood dyscrasias
  • History of any viral hepatitis within 1 year prior screening or history of any drug-induced liver injury at any time prior to screening
  • Laboratory exclusions are: hemoglobin level < 8,5 mg/dl white blood cell count < 3.5 x 10^9/l platelet count < 125 x 10^9 /l creatinine level > 175 mcmol/l, liver enzymes > 1.5 times the upper limit of normal or alkaline phosphatase > 2 times the upper limit of normal.
  • Participation in trials of other investigational medications within 30 days of entering the study
  • Clinical examination showing significant abnormalities of clinical relevance
  • Concomitant medication with disease-modifying anti-rheumatic drugs (DMARDs) or corticosteroids
  • History or current evidence of abuse of "hard" drugs (eg., cocaine/heroine) or alcoholism

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

  • Charite Campus Benjamin Franklin, Rheumatology

    Berlin, 12203

  • Rheumazentrum Ruhrgebiet

    Herne, 44652

Other trials in Germany

About this study

Official title: An Open-label Study of Etanercept (Enbrel) Efficacy in Ankylosing Spondylitis

The study has the aim to investigate the efficacy and safety of etanercept in patients with active ankylosing spondylitis (AS) over 520 weeks.

Being tested
Etanercept
Keywords
ankylosing spondylitis, atanercept, therapy, magnetic resonance imaging
Medical subject headings
Spondylitis, Ankylosing

What participants receive

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

  • EtanerceptDrug

    Also called Enbrel

    Etanercept 25 mg subcutaneously twice a week

Study groups in NCT01289743
Study groupRoleWhat they receive
Etanercept 25 mgExperimentalEtanercept 25 mg subcutaneously twice weekly
Receives: Drug: Etanercept

What is being measured

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

  1. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response

    Achievement of at least 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at week 12 as compared to baseline

    Measured: at week 12

Secondary outcomes (4)

  1. Sustained response

    Percentage of patients achieving the BASDAI50 response over time

    Measured: every 3 months througout the study

  2. Safety outcome

    Percentage of patients experienced adverse event during the study

    Measured: at 6 and 12 weeks, every 12 weeks thereafter

  3. Magnetic resonance imaging (MRI) response

    Reduction of inflammation seen on MRI in comparison to baseline

    Measured: at week 24, 54, 102, 210, 308, 416, 514

  4. X-ray progression

    Progression of the spinal structural changes as assessed by x-ray in comparison to baseline

    Measured: at week 54, 102, 210, 308, 514

Timeline

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

  1. First posted4 Feb 2011 (estimated)
  2. Study startFeb 2002
  3. Primary completionSep 2003
  4. Study completionMay 2012 (estimated)

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
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01289743
Sponsor's protocol ID
Enbrel _AS-2
Other IDs
202-04
Acronym
Enbrel_AS-2
Status last verified
Feb 2002
First submitted
1 Feb 2011
Last updated
4 Feb 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Baraliakos X, Haibel H, Fritz C, Listing J, Heldmann F, Braun J, Sieper J. Long-term outcome of patients with active ankylosing spondylitis with etanercept-sustained efficacy and safety after seven years. Arthritis Res Ther. 2013;15(3):R67. doi: 10.1186/ar4244.

    PubMed 23786760

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Etanercept in people with Ankylosing Spondylitis, run by Charite University, Berlin, Germany at 2 sites 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 9 inclusion and 14 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 4 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

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 Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)50 response (time frame: at week 12). 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 NCT01289743, which also lists 1 linked publication.

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 Feb 2011.

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