Study of the Human Anti-TNF Monoclonal Antibody in Patients With Active Rheumatoid Arthritis

NCT00649545 | Unknown

• 1 other identifier: M02-574
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to assess the safety (by collecting adverse events and serious adverse events) of adalimumab administered every other week to patients with moderately to severly active rheumatoid arthritis who have failed prior disease-modifying anti-rheumatic drugs (DMARDs).

Conditions

Rheumatoid Arthritis

Interventions

adalimumab BIOLOGICAL

40 mg every other week

Also known as: ABT-D2E7, Humira

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has completed (i.e. not dropped out of) the DE013 study or fulfills criteria 2-12
• Patients 18 years of age or older
• Female is either not childbearing, defined as post-menopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or if childbearing potential, practicing an acceptable method of birth control
• Female of childbearing potential must have a negative serum pregnancy test prior to first dose of adalimumab
• Diagnosis of active RA defined by \>= 5 swollen joints and one of the following:
• Positive RF
• One or more joint erosions present of x-ray
• HAQ score \> 1

You may not qualify if:

• Patient has failed 2 or more biologics
• Patient who had previous treatment with cyclophosphamide and chlorambucil
• Previous treatment with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibody resulting in presistent CD4 lymphopenia (CD4 lymphocytes +\< 500/mm3)
• History of cancer within the past 10 years unless successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix
• History of malignant lymphoma or leukemia regardless of treatment

Sponsors & Collaborators

• Abbott: lead

Related Publications (2)

• Burmester GR, Landewe R, Genovese MC, Friedman AW, Pfeifer ND, Varothai NA, Lacerda AP. Adalimumab long-term safety: infections, vaccination response and pregnancy outcomes in patients with rheumatoid arthritis. Ann Rheum Dis. 2017 Feb;76(2):414-417. doi: 10.1136/annrheumdis-2016-209322. Epub 2016 Jun 23.

  PMID: 27338778 DERIVED

• Haraoui B, Cividino A, Stewart J, Guerette B, Keystone EC. Safety and effectiveness of adalimumab in a clinical setting that reflects Canadian standard of care for the treatment of rheumatoid arthritis (RA): results from the CanACT study. BMC Musculoskelet Disord. 2011 Nov 17;12:261. doi: 10.1186/1471-2474-12-261.

  PMID: 22093579 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Last Updated: April 1, 2008

Record last verified: 2008-03