Clinical trial NCT01464021: A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China
Official title: A Post-Marketing Observational Study to Evaluate the Effectiveness of Adalimumab in Patients With Moderately to Severely Active Rheumatoid Arthritis in China
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis
Rheumatoid
Keywords: Study
prospective
Rheumatoid
Observational study
Arthritis
Adalimumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2011-11-03
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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 Disease Activity Score (DAS28) at Week 12. The maximum observation period for each patient is approximately 52 weeks, as long as the patient continues to receive adalimumab injections. The study was terminated due to low enrollment.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Patient meets the requirements for treatment with adalimumab per the local product label.
3. 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).
4. 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:

1. 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.
2. 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.
3. Patient who intends to take less than 6 consecutive (every other week) injections of adalimumab.
4. 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.

Primary outcomes:
measure: Number of Participants With at Least a Moderate European League Against Rheumatism (EULAR) Response
timeFrame: Week 12
Secondary outcomes:
measure: Percent Change From Baseline in Disease Activity Score (DAS)28 Erythrocyte Sedimentation Rate (ESR)
timeFrame: Weeks 4, 8, 12, 26
measure: Percent Change From Baseline in Tender and Swollen Joint Counts
timeFrame: Weeks 4, 8, 12, 26
measure: Percent Change From Baseline in C-reactive Protein
timeFrame: Weeks 4, 8, 12, 26
measure: Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
timeFrame: Weeks 4, 8, 12, 26
measure: Percent Change From Baseline in Patient's Global Assessment of Disease Activity
timeFrame: Weeks 4, 8, 12, 26
measure: Percent Change From Baseline in Patient's Assessment of Pain
timeFrame: Weeks 4, 8, 12, 26
measure: Percent Change From Baseline in Physician's Global Assessment of RA Disease Activity
timeFrame: Weeks 4, 8, 12, 26
measure: Percent Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
timeFrame: Weeks 4, 8, 12, 26
Other outcomes:
Locations:
city: Guangzhou City
country: China
facility: Site Reference ID/Investigator# 64782
city: Shanghai
country: China
facility: Site Reference ID/Investigator# 65702
city: Wulumuqi
country: China
facility: Site Reference ID/Investigator# 65706
Study officials:
affiliation: AbbVie
name: Dawn Carlson
role: STUDY_DIRECTOR
References: