A Study to Assess the Safety and Efficacy of Adalimumab When Added to Inadequate Standard Anti-Rheumatic Therapy in Patients With Active Rheumatoid Arthritis

NCT ID: NCT00448383

Last Updated: 2008-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 6610 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-09-30

Brief Summary

This is an open-label, multi-center study in which adalimumab (D2E7) is administered subcutaneously 40 mg every other week in addition to current anti-rheumatic therapies. Patients must have active disease despite standard anti-rheumatic therapy.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Open-label adalimumab

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

40mg every other week

Interventions

adalimumab

40mg every other week

Intervention Type: BIOLOGICAL

Other Intervention Names

ABT-D2E7; Humira

Eligibility Criteria

Inclusion Criteria

• Subjects must be 18 years or older
• ACR criteria for diagnosis of RA for at least 3 months.
• Active RA as defined by DAS28 >= 3.2 at study entry.
• Unsatisfactory response or intolerance to prior DMARDs.
• A negative pregnancy test (serum HCG) for women of childbearing potential prior to start of study treatment.
• Use of reliable method of contraception e.g. IUDs, condoms, or hormone (oral, implantable, or injectable) contraceptives by all female patients of childbearing potential. Male patients with procreative capacity should also ensure that effective contraception is used during the study and for 70 days after study completion

Exclusion Criteria

• Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil.
• Prior treatment with intravenous immunoglobulin or any investigational agent within 30 days, or 5 half lives of the product, whichever is longer.
• Prior treatment with investigational biologic therapy (e.g. anti CD4)
• Treatment within the last 2 months with approved biologic therapy (eg etanercept, infliximab, anakinra)
• Prior treatment with total lymphoid irradiation
• History of cancer or lymphoproliferative disease other than a successfully and completely treated squamous cell or basal cell carcinoma.
• History of or current acute inflammatory joint disease of origin other than RA, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
• History of uncontrolled diabetes, unstable ischemic heart disease, active inflammatory bowel disease, active peptic ulcer disease, recent stroke (within 3 months) and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
• Positive serology for hepatitis B or C indicating active infection
• History of positive HIV status.
• Persistent infection, or severe infections requiring hospitalization or treatment with iv antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
• Female subjects who are pregnant or breast-feeding.
• History of clinically significant drug or alcohol abuse in the last year.
• Previous diagnosis or signs of demyelinating diseases
• History of active tuberculosis (TB), histoplasmosis or listeriosis.
• Signs of previous TB infection (chest X-ray signs or positive PPD skin test). The diagnosis of previous TB infection will be based on chest X-ray signs and on PPD skin test.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abbott

INDUSTRY

Sponsor Role: lead

Responsible Party

Abbott

Principal Investigators

Beverly Paperiello

Role: STUDY_DIRECTOR

Abbott

References

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.

Reference Type: DERIVED

PMID: 27338778 (View on PubMed)

Burmester GR, Matucci-Cerinic M, Mariette X, Navarro-Blasco F, Kary S, Unnebrink K, Kupper H. Safety and effectiveness of adalimumab in patients with rheumatoid arthritis over 5 years of therapy in a phase 3b and subsequent postmarketing observational study. Arthritis Res Ther. 2014 Jan 27;16(1):R24. doi: 10.1186/ar4452.

Reference Type: DERIVED

PMID: 24460746 (View on PubMed)

Burmester GR, Ferraccioli G, Flipo RM, Monteagudo-Saez I, Unnebrink K, Kary S, Kupper H. Clinical remission and/or minimal disease activity in patients receiving adalimumab treatment in a multinational, open-label, twelve-week study. Arthritis Rheum. 2008 Jan 15;59(1):32-41. doi: 10.1002/art.23247.

Reference Type: DERIVED

PMID: 18163417 (View on PubMed)

Other Identifiers

M02-497

Identifier Type: -

Identifier Source: org_study_id