Rheumatoid ArthritisENBREL NIS CNNCT01411215
A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Pfizer at 15 sites in China.
Trial summary
This is an open-label, multicenter and observational study in China, which is designed to record the data of RA \& AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Ankylosing Spondylitis
- What is being tested?
- Enbrel
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 15 sitesChina
- Study dates
- Jan 2011to Jan 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: outpatient RA and AS patients in China
Who may be able to join
- Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.
- Subject has accepted physician's prescription of etanercept in rheumatology department.
- Subject agreed to be enrolled in the observational study and sign the ICD.
- Subject is≥18 years of age at the time of consent.
- Subject is willing and able to understand and complete questionnaires
Who cannot join
- Presence of active or suspected latent infection including HIV, or any underlying disease, including open cutaneous ulcers that could predispose the subject to infections.
- Immunodeficiency syndromes including Felty syndrome or large granular lymphocyte syndrome.
- Active tuberculosis (TB) or a history of TB, or findings consistent with previous exposure to TB on a chest x-ray (CXR). Investigators must follow China's guidelines for appropriate screening and treatment of TB.
- History of hypersensitivity to any of the ingredients in either preparation.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
The First Affiliated Hospital of Baotou Medical College
Baotou, Inner Mongolia, 014010
Baotou Central Hospital
Baotou
Shanghai Changning Guanghua Integrative Medicine Hospital
Beijing, 200052
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Si Chuan Huaxi Hospital/Rheumatology Department
Chengdu, Sichuan, 610041
Daping Hospital
Chongqing, Chongqing Municipality, 400038
Fujian Provincial Hospital
Fuzhou, Fujian, 350001
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, 510405
No. 199
Haerbin, Heilongjiang, 150001
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030
Jiangsu Province Hospital/Department of Rheumatology
Nanjing, Jiangsu, 210029
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Shanghai Jiaotong University Affiliated Third People's Hospital
Shanghai, 201900
The Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, 830001
About this study
Official title: A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department
This is an open-label, multicenter and observational study in China, which is designed to record the data of RA \& AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible subjects agreed to be recruited in the study and can withdraw anytime if they choose so.
Patients with RA or AS are typically managed by rheumatologists. As this study seeks to record the data of RA \& AS patient in etanercept and evaluate the safety and efficacy of the treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked to build up the database for RA \& AS patient surveillance prospectively in outpatient dept, which benefits for the patient treatment outcomes evaluation and clinical management.
Read the detailed description
The primary objective of this non-interventional study is to evaluate the safety of etanercept in Chinese RA and AS subjects. Total of 600 subjects (300 RA subjects and 300 AS subjects) will be enrolled in the study. If the true rate of an adverse event is no less than 0.5%, with sample size of 600 subjects, this study will have 95% probability to detect at least one occurrence of the adverse event. The study prematurely discontinued on January 15, 2013 due to slow enrollment and low adherence of etanercept. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis
- Being tested
- Enbrel
- Keywords
- Rheumatoid arthritis, ankylosing spondylitis, observational study
- Medical subject headings
- Arthritis, Rheumatoid, Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnbrelDrug
Also called etanercept
25mg biweekly or 50mg per week, subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| RA, AS | Rheumatoid arthritis patients Ankylosing spondylitis patients Receives: Drug: Enbrel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: First day of receiving etanercept through 24 weeks
Number of Participants Who Had Any AEs During 52 Weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Measured: First day of receiving etanercept through 52 weeks
Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks
An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Informed consent or signed data privacy statement through 24 weeks
Number of Participants Who Had Any SAEs During 52 Weeks
An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Measured: Informed consent or signed data privacy statement through 52 weeks
Number of Participants With AEs Per System Organ Class During 24 Weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.
Measured: First day of receiving etanercept through 24 weeks
Number of Participants With AEs Per System Organ Class During 52 Weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.
Measured: First day of receiving etanercept through 52 weeks
Secondary outcomes (11)
Physician's Global Assessment of Disease Activity
Physicians indicated on a 0-100 millimeters (mm) visual analogue scale (VAS) to assess the activity of the participant's disease according to the participant's clinical condition, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Participant's Global Assessment (PtGA) of Disease Activity
Participants placed a vertical line on a 0-100 mm VAS to indicate the magnitude of their global disease activity, with 0 meaning no disease activity (disease inactive) and 100 meaning extreme disease activity (disease extremely active).
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
VAS Score for Pain
Participants placed a mark on a 0-100 mm VAS to indicate the magnitude of pain, with 0 meaning no pain and 100 meaning the most severe pain.
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%
Treatment adherence rate was calculated using the following formula: [Actual dosing/expected dosing on the basis of approved product label] × 100%. Counts of participants by 6 levels of treatment adherence rate: 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%.
Measured: First day of receiving etanercept up to Week 52
Evaluate the Association Between Participant's Age and Treatment Adherence Rate
Participants were allocated to 5 groups by age as 10 years separately: <20 years, >=20 and <30 years, >=30 and <40 years, >=40 and <50 years, >50 years. The number of participants with treatment adherence rate 1), <50%, 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% were provided for each age group described above.
Measured: First day of receiving etanercept up to Week 52
Number of Participants With Any Abnormal Laboratory Test Results
Number of participants with any abnormal laboratory test results, criteria for abnormalities were complete blood count (CBC) including hemoglobin (<0.8*lower limit of normal[LLN]), mean corpuscular volume (MCV, <0.9*LLN or >1.1*upper limit of normal[ULN]), hematocrit (<0.8*LLN), red blood cell count (<0.8*LLN), platelets (<0.5*LLN or >1.75*ULN), white blood cell count (<0.6*LLN or >1.5*ULN), lymphocytes (<0.8*LLN or >1.2*ULN), neutrophils (<0.8*LLN or >1.2*ULN), basophil (>1.2*ULN), eosinophil (>1.2*ULN), and monocytes (>1.2*ULN); ESR (>1.5*ULN); aspartate aminotransferase (AST,>3.0*ULN); alanine aminotransferase (ALT,>3.0*ULN); blood urea nitrogen (BUN,>1.3*ULN); and creatinine (CRE,>1.3*ULN).
Measured: Baseline (Week 0) up to Week 52
Tender Joint Count (TJC) for RA Participants
TJC (28 joints) include the joints of shoulders, elbows, wrists, metacarpophalangeal (MCP), proximal interphalangeal (PIP), and the knees. The joints were assessed for tenderness using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Swollen Joint Count (SJC) for RA Participants
SJC (28 joints) include the joints of shoulders, elbows, wrists, MCP, PIP, and the knees. The joints were assessed for swelling using the following scale: Present (1), Absent (2), Not Done (3), Not Applicable (4). Artificial joints were not assessed.
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
DAS28-4 (ESR) was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) and PtGA of disease activity on a 0-100 mm VAS: DAS28-4 (ESR)=0.56*square root(TJC 28 joints) + 0.28*square root(SJC 28 joints) + 0.70*ln(ESR) + 0.014*PtGA. DAS28-4 (ESR) above 5.1 indicated high disease activity whereas a DAS28-4 (ESR) below 3.2 indicated low disease activity.
Measured: Baseline (Week 0), Week 2, Week 4, Week 12, Week 52
Number of RA Participants Had DAS28-4 (ESR) Improvement
Counts of participants had good, moderate and no response to treatment with etanercept. Good response was present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >1.2. Moderate response was 1) present DAS28-4 (ESR) >3.2 and <=5.1, DAS28-4 (ESR) improvement from baseline >1.2, or >0.6 and <=1.2; 2) present DAS28-4 (ESR) <=3.2, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2; or 3) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline > 1.2. No response was 1) DAS28-4 (ESR) improvement from baseline <=0.6 regardless present DAS28-4 (ESR), or 2) present DAS28-4 (ESR) >5.1, DAS28-4 (ESR) improvement from baseline >0.6 and <=1.2.
Measured: Week 2, Week 4, Week 8, Week 12, Week 36, Week 52
Number of RA Participants Had Remission of Disease
Counts of participants had remission of disease. Remission of disease was defined by a DAS28-4 (ESR) <2.6.
Measured: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: See termination reason in detailed description.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411215
- Sponsor's protocol ID
- B1801044
- Acronym
- ENBREL NIS CN
- Status last verified
- Jan 2014
- First submitted
- 13 May 2011
- Last updated
- 6 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department
- ClinicalTrials.gov ID
- NCT01411215
- Acronym / sponsor ID
- ENBREL NIS CN / B1801044
- Conditions
- Rheumatoid Arthritis, Ankylosing Spondylitis
- Keywords
- Rheumatoid arthritis, ankylosing spondylitis, observational study
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: See termination reason in detailed description.
- Enrolment
- 160 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 8 Aug 2011 (estimated)
- Results
- Posted 6 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, multicenter and observational study in China, which is designed to record the data of RA \& AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible subjects agreed to be recruited in the study and can withdraw anytime if they choose so.
Patients with RA or AS are typically managed by rheumatologists. As this study seeks to record the data of RA \& AS patient in etanercept and evaluate the safety and efficacy of the treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked to build up the database for RA \& AS patient surveillance prospectively in outpatient dept, which benefits for the patient treatment outcomes evaluation and clinical management.
Detailed description
The primary objective of this non-interventional study is to evaluate the safety of etanercept in Chinese RA and AS subjects. Total of 600 subjects (300 RA subjects and 300 AS subjects) will be enrolled in the study. If the true rate of an adverse event is no less than 0.5%, with sample size of 600 subjects, this study will have 95% probability to detect at least one occurrence of the adverse event. The study prematurely discontinued on January 15, 2013 due to slow enrollment and low adherence of etanercept. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RA, AS | – | Drug: EnbrelRheumatoid arthritis patients Ankylosing spondylitis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient RA and AS patients in China
Key inclusion criteria (5 listed)
- Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.
- Subject has accepted physician's prescription of etanercept in rheumatology department.
- Subject agreed to be enrolled in the observational study and sign the ICD.
- Subject is≥18 years of age at the time of consent.
- Subject is willing and able to understand and complete questionnaires
Key exclusion criteria (4 listed)
- Presence of active or suspected latent infection including HIV, or any underlying disease, including open cutaneous ulcers that could predispose the subject to infections.
- Immunodeficiency syndromes including Felty syndrome or large granular lymphocyte syndrome.
- Active tuberculosis (TB) or a history of TB, or findings consistent with previous exposure to TB on a chest x-ray (CXR). Investigators must follow China's guidelines for appropriate screening and treatment of TB.
- History of hypersensitivity to any of the ingredients in either preparation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EnbrelAlso: etanercept25mg biweekly or 50mg per week, subcutaneous injection | Drug | RA, AS |
Primary outcome
Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks
Time frame: First day of receiving etanercept through 24 weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of Participants Who Had Any AEs During 52 Weeks
Time frame: First day of receiving etanercept through 52 weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.
Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks
Time frame: Informed consent or signed data privacy statement through 24 weeks
An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants Who Had Any SAEs During 52 Weeks
Time frame: Informed consent or signed data privacy statement through 52 weeks
An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Number of Participants With AEs Per System Organ Class During 24 Weeks
Time frame: First day of receiving etanercept through 24 weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.
Number of Participants With AEs Per System Organ Class During 52 Weeks
Time frame: First day of receiving etanercept through 52 weeks
An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.
11 secondary outcomes
Physician's Global Assessment of Disease Activity
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Participant's Global Assessment (PtGA) of Disease Activity
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
VAS Score for Pain
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120%
Time frame: First day of receiving etanercept up to Week 52
Evaluate the Association Between Participant's Age and Treatment Adherence Rate
Time frame: First day of receiving etanercept up to Week 52
Number of Participants With Any Abnormal Laboratory Test Results
Time frame: Baseline (Week 0) up to Week 52
Tender Joint Count (TJC) for RA Participants
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Swollen Joint Count (SJC) for RA Participants
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52
Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR])
Time frame: Baseline (Week 0), Week 2, Week 4, Week 12, Week 52
Number of RA Participants Had DAS28-4 (ESR) Improvement
Time frame: Week 2, Week 4, Week 8, Week 12, Week 36, Week 52
Number of RA Participants Had Remission of Disease
Time frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Ankylosing Spondylitis, run by Pfizer at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks (time frame: First day of receiving etanercept through 24 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2014.