Open Label Study to Assess Efficacy and Safety of the Fully Human Anti-TNF-Alpha Monoclonal Antibody Adalimumab

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

APPROVED_FOR_MARKETING

Study Classification

EXPANDED_ACCESS

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study was to explore the efficacy of adalimumab in subjects previously treated with infliximab and failed infliximab treatment due to lack of efficacy or intolerance. To explore the safety of adalimumab in subjects previously treated with infliximab.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

adalimumab

40 mg adalimumab every other week

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ABT-D2E7 Humira

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Males and females \>= 18 years of age
* ACR criteria for RA diagnosis for at least 6 months
* Active RA defined as a DAS 28 \>3.2 at study entry
* Unsatisfactory response, loss of response or intolerance to prior infliximab treatment
* A negative pregnancy test for females of childbearing potential

Exclusion Criteria

* Patient who had previous treatment with cyclophosphamide and chlorambucil
* Treatment within the last 8 weeks with infliximab
* Prior treatment with more than one DMARD or DMARD combination following infliximab treatment
* Prior treatment with biologics (Investigational or Commercial) RA therapies other than infliximab
* History of cancer, other than successfully treated squamous cell or basal cell carcinoma or lymphoproliferative disease
* Prior treatment with total lymphoid irradiation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abbott

References

Explore related publications, articles, or registry entries linked to this study.

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)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M02-532

Identifier Type: -

Identifier Source: org_study_id