Effectiveness and Safety of Spondylitis Related to Inflammatory Bowel Disease

NCT00972218 | Withdrawn Phase 4

• 1 other identifier: A10-456
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Spondyloarthritis; Crohn's Disease

Keywords

Spondyloarthritis; Ankylosing Spondylitis; Crohn's disease; adalimumab; treatment

Outcome Measures

Primary Outcomes (1)

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

  24 weeks

Secondary Outcomes (17)

• ASAS 20 response

  12 weeks

• ASAS 40, 50, 70, 5/6 responses

  12 and 24 weeks

• Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  12 and 24 weeks

• Bath Ankylosing Spondylitis Functional Index (BASFI)

  12 and 24 weeks

• Patient Global Assessment of arthritic and CD-related disease activity

  12 and 24 weeks

Study Arms (1)

Enteropathic spondyloarthritis

EXPERIMENTAL

Patients have concomitant inflammatory spinal symptoms and inflammatory bowel disease.

Biological: Adalimumab

Interventions

Adalimumab BIOLOGICAL

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

Also known as: Humira

Enteropathic spondyloarthritis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Abbott: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G2S2, Canada

Location

MeSH Terms

Conditions

Spondylarthritis; Crohn Disease; Spondylitis, Ankylosing

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Axial Spondyloarthritis; Spondylarthropathies; Ankylosis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Walter P Maksymowych, FRCP(C)

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2009
• First Posted: September 4, 2009
• Study Start: July 1, 2009
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: September 16, 2016

Record last verified: 2016-09

Locations

CA (1)