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SpondyloarthritisPhase 4NCT00972218

Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease

A Phase 4 study testing Adalimumab in people with Spondyloarthritis and Crohn's Disease, run by University of Alberta at 1 site in Canada.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

Adalimumab is an antibody treatment that targets and neutralizes a molecule produced in the body that is associated with inflammation, tumor necrosis factor (TNF). This molecule is an important factor in causing the inflammation seen in people with a form of inflammatory spinal arthritis called spondylitis as well as… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Spondyloarthritis, Crohn's Disease
What is being tested?
Adalimumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteCanada
Study dates
Jul 2009to Jan 2010
Phase
Phase 4
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

  • Patient is 18 years of age or older
  • Patient has a clinical diagnosis with Crohn's disease, as determined by his/her medical history and confirmation of diagnosis by a gastroenterologist
  • Patient has either moderate to severely active Crohn's disease as defined by a CDAI score of > 220 and < 450 at Screening or active inflammatory back pain as defined by a BASDAI ≥ 4
  • Subject has failed to respond to an adequate course, is intolerant to, or has contraindication to eitherach of the following therapies: Corticosteroids (Prednisone/Budesonide),MTX or Azathioprine/6-mercaptopurine
  • Patient is on stable (≥ 1 month) concurrent therapies for Crohn's disease, including 5-aminosalicylates, prednisone (<20 mg/day), budesonide (<9 mg/day), azathioprine, 6-mercaptopurine, methotrexate, and antibiotics
  • If female, patient is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control:condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD),contraceptives (oral or parenteral) for three months (90 days) prior to study drug administration), a vasectomized partner, total abstinence from sexual intercourse
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  • If patient is female and of childbearing potential, the results of a serum pregnancy test performed at Screening, prior to the first dose of adalimumab, must be negative
  • Patient has Crohn's disease for at least 4 months
  • Patient has not taken NSAIDs (including OTC) for ≥2 weeks
  • Patient has inflammatory back pain according to the Calin or Rudwaleit criteria
  • Patient is able and willing to self-administer sc injections or has available a qualified person(s) to administer sc injections
  • Patient is able to give written informed consent and to complete the study requirements.

Who cannot join

  • Patient has current diagnosis of colitis other than Crohn's disease
  • Patient has symptomatic known strictures
  • Surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study
  • Ostomy or ileoanal pouch
  • Short bowel syndrome as determined by the investigator
  • Patient has received prior treatment with intravenous immunoglobulin or any investigational agents within four weeks of Baseline, or five half-lives of the product, whichever was longer
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  • Patient has been previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in persistent CD4 lymphopenia (CD4 lymphocytes < 500/mm3)
  • Patient was previously exposed to a biologic TNF-inhibitor
  • Patient has a history of cancer or lymphoproliferative disease other than: Successfully and completely treated Cervical dysplasia, with no recurrence within the last five years
  • Has a history of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure, New York Heart Association (NYHA) III, IV, recent stroke (within three months), chronic leg ulcer and any other condition (e.g., indwelling urinary catheter) which, in the opinion of the Investigator, would put the subject at risk by participation in the protocol or who would make the subject unsuitable for the study
  • Positive serology for hepatitis B indicating acute or chronic infection
  • Subject is known to have immune deficiency, history of human immunodeficiency virus (HIV) or is immunocompromised
  • Persistent or recurrent or severe infections requiring hospitalization or treatment with intra-venous (IV) antibiotics within 30 days, or oral antibiotics within 14 days, prior to Baseline
  • Female subjects who are pregnant or breastfeeding
  • Has a history of an allergic reaction or significant sensitivity to constituents of adalimumab
  • Has a history of clinically significant drug or alcohol abuse in the last year
  • Previous diagnosis or signs of central nervous system demyelinating diseases (e.g., optic neuritis, visual disturbance, gait disorder/ataxia, facial paresis, apraxia)
  • Patient has a history of active tuberculosis (TB), histoplasmosis or listeriosis, or other currently active infections suggestive of significant or profound immunosuppression, such as Pneumocystis carinii, aspergillosis or other systemic infections
  • Patient has latent TB (positive PPD skin test) or has other risk factors for the activation of latent TB, e.g. previous exposure to TB, and has not initiated TB prophylaxis prior to the first adalimumab treatment. In either case, the Principal Investigator (sponsor) must be contacted before initiating the study treatment (see Section 5.6.4, "Screening for Latent Tuberculosis)
  • Subjects will be excluded if the CXR is found to have changes suggestive of old healed tuberculous lesion (e.g. calcified nodule, fibrotic scar, apical or basilar pleural thickening etc.)
  • Patient has any condition that would prevent participation or completion in this study, including language limitation or possibility that the patient will not be available for the complete study period
  • Patient, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Alberta

    Edmonton, Alberta, T6G2S2

Other trials in Canada

About this study

Official title: Efficacy of Adalimumab (Humira®) in Spondyloarthritis Related to Crohn's Disease

Adalimumab is an antibody treatment that targets and neutralizes a molecule produced in the body that is associated with inflammation, tumor necrosis factor (TNF). This molecule is an important factor in causing the inflammation seen in people with a form of inflammatory spinal arthritis called spondylitis as well as inflammation in the bowel called Crohn's disease. Spondylitis and Crohn's disease tend to go together and this study will assess to what degree this treatment is effective for those patients that have both disorders at the same time.

Read the detailed description

The primary objective of the present study is to assess the efficacy of adalimumab in ameliorating the signs and symptoms of spondyloarthritis associated with CD. Although AS patients with IBD were recruited in phase III trials of anti-TNF therapy and shown to respond to treatment, this has not been established in a cohort of patients with exclusive enteropathic spondyloarthritis. Evaluation of such a cohort will address several important issues:

  • Firstly, it will answer the question of whether or not patients with enteropathic spondyloarthritis respond to treatment with adalimumab.
  • Secondly, since patients with IBD represent a cohort at high risk of developing spondyloarthritis, this approach will allow the study of the efficacy of adalimumab in patients with pre-radiographic inflammatory back pain as determined by clinical, laboratory, and radiological outcomes. In particular, the use of MRI as an outcome measure will be explored. In addition, this will allow the further evaluation of diagnostic criteria for pre-radiographic AS.
  • Thirdly, the efficacy of adalimumab in treating IBD associated with SpA has not been previously determined. It has been assumed that the response should be the same as that observed in idiopathic disease. However, it is important to note that the bowel disease related to spondyloarthritis has different genetic associations from idiopathic disease and may have a different underlying pathophysiology. Several biomarkers have been shown to reflect response to anti-TNF therapies in spondyloarthritis e.g. MMP3 and VEGF. However, other surrogates of disease, such as bowel permeability, have yet to be examined.
Being tested
Adalimumab
Keywords
Spondyloarthritis, Ankylosing Spondylitis, Crohn's disease, adalimumab, treatment
Medical subject headings
Spondylarthritis, Crohn Disease, Spondylitis, Ankylosing

What participants receive

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

  • AdalimumabBiological

    Also called Humira

    Adalimumab subcutaneous injections 40 mg dose every other week for 24 weeks

Study groups in NCT00972218
Study groupRoleWhat they receive
Enteropathic spondyloarthritisExperimentalPatients have concomitant inflammatory spinal symptoms and inflammatory bowel disease.
Receives: Biological: Adalimumab

What is being measured

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

  1. The primary efficacy outcome measure will be the Ankylosing Spondylitis Assessment Study group 20 (ASAS 20) response at 24 weeks.

    Measured: 24 weeks

Secondary outcomes (17)

  1. ASAS 20 response

    Measured: 12 weeks

  2. ASAS 40, 50, 70, 5/6 responses

    Measured: 12 and 24 weeks

  3. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

    Measured: 12 and 24 weeks

  4. Bath Ankylosing Spondylitis Functional Index (BASFI)

    Measured: 12 and 24 weeks

  5. Patient Global Assessment of arthritic and CD-related disease activity

    Measured: 12 and 24 weeks

  6. Total Back Pain

    Measured: 12 and 24 weeks

  7. Nocturnal Back Pain

    Measured: 12 and 24 weeks

  8. Erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP)

    Measured: 12 and 24 weeks

  9. Patient Acceptable Symptom State (PASS) assessments

    Measured: 12 and 24 weeks

  10. Spinal mobility assessment

    Measured: 2 and 24 weeks

  11. Enthesitis assessment

    Measured: 12 and 24 weeks

  12. Crohn's Disease Activity Index (CDAI)

    Measured: 12 and 24 weeks

  13. Short form 36 (SF-36™)

    Measured: 12 and 24 weeks

  14. Helplessness scale

    Measured: 12 and 24 weeks

  15. Spondyloarthritis Research Consortium of Canada Magnetic Resonance Imaging Index (SPARCC MRI)

    Measured: 24 weeks

  16. Serum biomarkers matrix metalloproteinase 3 (MMP3), vascular endothelial growth factor (VEGF), DKK-1, Wnt, RANKL, OPG and cytokines (e.g. IL17, IL23, IL18)

    Measured: 12 and 24 weeks

  17. Bowel permeability

    Measured: 12 and 24 weeks

Timeline

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

  1. First posted4 Sep 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionJan 2010
  4. Study completionJan 2010

Why it stopped: Difficulty with enrollment

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 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00972218
Sponsor's protocol ID
A10-456
Status last verified
Sep 2016
First submitted
31 Aug 2009
Last updated
16 Sep 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adalimumab in people with Spondyloarthritis and Crohn's Disease, run by University of Alberta at 1 site in Canada.

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 12 inclusion and 22 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: withdrawn, as of the sponsor's last update on 16 Sep 2016. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 was withdrawn before enrolling participants, so there are no results.

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 primary efficacy outcome measure will be the Ankylosing Spondylitis Assessment Study group 20 (ASAS 20) response at 24 weeks. (time frame: 24 weeks). 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 NCT00972218.

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 16 Sep 2016.

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