Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 26 September 2016
• Main ID: NCT00972218
• Date of registration: 31/08/2009
• Prospective Registration: No
• Primary sponsor: University of Alberta
• Public title: Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease
• Scientific title: Efficacy of Adalimumab (Humira®) in Spondyloarthritis Related to Crohn's Disease
• Date of first enrolment: July 2009
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: https://clinicaltrials.gov/show/NCT00972218
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Canada

Contacts

• Name: Walter P Maksymowych, FRCP(C)
• Affiliation: University of Alberta

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

- 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.

Exclusion criteria

- 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

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Spondyloarthritis

Intervention(s)

Biological: Adalimumab

Primary Outcome(s)

The primary efficacy outcome measure will be the Ankylosing Spondylitis Assessment Study group 20 (ASAS 20) response at 24 weeks. [Time Frame: 24 weeks]

Secondary Outcome(s)

Spinal mobility assessment [Time Frame: 2 and 24 weeks]

ASAS 20 response [Time Frame: 12 weeks]

Erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP) [Time Frame: 12 and 24 weeks]

Nocturnal Back Pain [Time Frame: 12 and 24 weeks]

Crohn's Disease Activity Index (CDAI) [Time Frame: 12 and 24 weeks]

Enthesitis assessment [Time Frame: 12 and 24 weeks]

Patient Acceptable Symptom State (PASS) assessments [Time Frame: 12 and 24 weeks]

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: 12 and 24 weeks]

Bowel permeability [Time Frame: 12 and 24 weeks]

Patient Global Assessment of arthritic and CD-related disease activity [Time Frame: 12 and 24 weeks]

Serum biomarkers matrix metalloproteinase 3 (MMP3), vascular endothelial growth factor (VEGF), DKK-1, Wnt, RANKL, OPG and cytokines (e.g. IL17, IL23, IL18) [Time Frame: 12 and 24 weeks]

Spondyloarthritis Research Consortium of Canada Magnetic Resonance Imaging Index (SPARCC MRI) [Time Frame: 24 weeks]

Total Back Pain [Time Frame: 12 and 24 weeks]

Helplessness scale [Time Frame: 12 and 24 weeks]

Short form 36 (SF-36™) [Time Frame: 12 and 24 weeks]

ASAS 40, 50, 70, 5/6 responses [Time Frame: 12 and 24 weeks]

Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: 12 and 24 weeks]

Secondary ID(s)

A10-456

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Abbott