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

NCT01464021 | Terminated Results

• 1 other identifier: P13-194
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Arthritis; Rheumatoid

Keywords

Study; prospective; Rheumatoid; Observational study; Arthritis; Adalimumab

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response

  A EULAR response reflects improvement in disease activity and attainment of a lower degree of disease activity based on the Disease Activity Score (DAS)28 score. The DAS28 score ranges from 0-10, with higher scores indicating more disease activity. A Good Response is defined as an improvement (decrease) in the DAS28 of more than 1.2 compared with Baseline and attainment of a DAS28 score of less than or equal to 3.2. A Moderate Response is defined as either: an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 from Baseline and attainment of a DAS28 score of less than or equal to 5.1 or, an improvement (decrease) in the DAS28 of more than 1.2 from Baseline and attainment of a DAS28 score of greater than 3.2. No Response is defined as either an improvement (decrease) in the DAS28 of less than or equal to 0.6, or an improvement (decrease) in the DAS28 of greater than 0.6 and less than or equal to 1.2 and attainment of a DAS28 of more than 5.1

  Week 12

Secondary Outcomes (8)

• Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)

  Weeks 4, 8, 12, 26

• Percent Change From Baseline in Tender and Swollen Joint Counts

  Weeks 4, 8, 12, 26

• Percent Change From Baseline in C-reactive Protein

  Weeks 4, 8, 12, 26

• Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

  Weeks 4, 8, 12, 26

• Percent Change From Baseline in Patient's Global Assessment of Disease Activity

  Weeks 4, 8, 12, 26

Study Arms (1)

Adalimumab

Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.

Eligibility Criteria

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

Study Population

Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.

You may qualify if:

• 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.

You may not qualify if:

• 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, there should be documentation that a full course of appropriate anti-TB therapy was completed or an ongoing full course of appropriate anti-TB 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (3)

Site Reference ID/Investigator# 64782

Guangzhou, 510080, China

Location

Site Reference ID/Investigator# 65702

Shanghai, 200052, China

Location

Site Reference ID/Investigator# 65706

Ürümqi, 830001, China

Location

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood, serum

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Limitations and Caveats

The study was terminated early due to low enrollment and high drop-out rate. Only serious adverse events and events leading to discontinuation were collected.

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Dawn Carlson

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 3, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 6, 2014
• Results First Posted: January 30, 2014

Record last verified: 2014-02

Locations

CN (3)