A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China - Full Text View

Purpose

A post-marketing uncontrolled observational study to explore and describe the effectiveness of adalimumab, as prescribed according to the local product label, in patients with moderately to severely active rheumatoid arthritis (RA) in China.

Condition
Arthritis Rheumatoid

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

Drug Information available for: Adalimumab

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

The percentage of patients with at least a moderate EULAR(European League Against Rheumatism) response at week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in DAS(Disease Activity Score)28(ESR) at all timepoints compared to Baseline [ Time Frame: Baseline, Weeks 4, 8, 12, 26, 38 and 52/Early Termination ] [ Designated as safety issue: No ]
Change in tender and swollen joint count at all timepoints compared to Baseline [ Time Frame: Baseline, Weeks 4, 8, 12, 26, 38 and 52/Early Termination ] [ Designated as safety issue: No ]
Change in C-reactive protein (CRP) at all timepoints compared to Baseline [ Time Frame: Baseline, Weeks 4, 8, 12, 26, 38 and 52/Early Termination ] [ Designated as safety issue: No ]
Change in Erythrocyte Sedimentation Rate (ESR) at all timepoints compared Baseline [ Time Frame: Baseline, Weeks 4, 8, 12, 26, 38 and 52/Early Termination ] [ Designated as safety issue: No ]
Change in Patient's Global Assessment of Disease Activity at all timepoints compared to Baseline [ Time Frame: Baseline, Weeks 4, 8, 12, 26, 38 and 52/Early Termination ] [ Designated as safety issue: No ]
Change in Patient's Assessment of Pain at all timepoints compared to Baseline [ Time Frame: Baseline, Weeks 4, 8, 12, 26, 38 and 52/Early Termination ] [ Designated as safety issue: No ]
Change in Physician's Global Assessment of Disease Activity at all timepoints compared to Baseline [ Time Frame: Baseline, Weeks 4, 8, 12, 26, 38 and 52/Early Termination ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Whole blood, serum

Estimated Enrollment:	500
Study Start Date:	December 2011
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts
Adalimumab group Chinese adult patients with a diagnosis of RA (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Patients must be naïve to adalimumab at the Baseline visit.

Detailed Description:

This post-marketing, multi-center, uncontrolled observational study will be conducted in an open-label, non-interventional setting, for RA patients using commercially available adalimumab administered subcutaneously (SC).Adalimumab effectiveness will be assessed based on data from clinic visits beginning at Baseline and continuing per standard of care for RA. The primary objective is to evaluate the effectiveness of adalimumab in improving patients; disease activity measured by DAS 28 at week 12.The maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Adult patients with a diagnosis of RA (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Patients must be naïve to adalimumab at the Baseline visit.

Criteria

Inclusion Criteria:

Male or female patient greater than or equal to 18 years of age with diagnosis of RA(Rheumatoid Arthritis) and no history of chronic arthritis before age 16.
Patient meets the requirements for treatment with adalimumab per the local product label.
Patient is naïve to adalimumab, and has not used any other immunomodulatory biologic* DMARD(Disease Modifying Antirheumatic Drugs) in the past 8 weeks before the Baseline visit (*rituximab may not have been used in the past 104 weeks before the Baseline visit).
Patient must be able and willing to provide written authorization (or informed consent where applicable) to disclose and use personal health information and comply with the requirements of this study protocol as well as agree to data being collected by Abbott.

Exclusion Criteria:

Patient is currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days or five half lives (whichever is longer) of the drug prior to the Baseline visit.
Prior clinically active TB(Tuberculosis): if patient has had prior clinically active TB(Tuberculosis), there should be documentation that a full course of appropriate anti-TB(Tuberculosis) therapy was completed or an ongoing full course of appropriate anti-TB(Tuberculosis) therapy has been started before initiation of adalimumab in accordance with the local product label; otherwise, the patient will not be eligible to participate in this study.
Patient who intends to take less than 6 consecutive (every other week) injections of adalimumab.
Patients should not be enrolled if they cannot be treated with adalimumab in accordance with the local product label or if the Investigator determines that they should not be enrolled based on his/her clinical judgment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01464021

Contacts

Contact: Yan KANG, MS	86-10-68028080-238	snow.kang@abbott.com
Contact: Rachel TANG	86-21-62631346	rachel.tang@abbott.com

Locations

China
Site Reference ID/Investigator# 64782	Recruiting
Guangzhou City, China, 510080
Principal Investigator: Site Reference ID/Investigator# 64782
Site Reference ID/Investigator# 65702	Completed
Shanghai, China, 200052

Sponsors and Collaborators

Abbott (China)

Investigators

Study Director:

Dawn Carlson

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie ( Abbott (China) )
ClinicalTrials.gov Identifier:	NCT01464021 History of Changes
Other Study ID Numbers:	P13-194
Study First Received:	October 31, 2011
Last Updated:	March 19, 2013
Health Authority:	China: Ethics Committee

Keywords provided by AbbVie:

Study
prospective
Rheumatoid

Observational study
Arthritis
Adalimumab

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases

Immune System Diseases
Adalimumab
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013