Trial · NCT01646385

Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry

NCT01646385, Completed, Pfizer; results first posted 2014-08-05

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry. Trials, record NCT01646385. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01646385

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study to Assess the Safety and Efficacy of Etanercept in Patients Treated Over the Long-term in Real-world Clinical Practice, Using Data Collected by the British Society of Rheumatology Biologics Registry
NCT number: NCT01646385
Status: Completed
Enrollment: 6,393 participants, actual
Lead sponsor: Pfizer
Conditions: Rheumatoid Arthritis
Interventions: etanercept, non-biologic anti-rheumatic drugs
First posted: 2012-07-20
Last updated: 2014-08-05
Results first posted: 2014-08-05

Source ClinicalTrials.gov

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Crude Incidence Rate of Malignancy	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of malignancy events divided by Participant-Year, multiplied by 1000.
Primary	Crude Incidence Rate of Lymphoproliferative Malignancy (LM)	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Participant-Year estimated by calculating all of years that participants in a study were followed (number of evaluable participants multiplied by mean follow-up in years). Crude (unadjusted) incidence rate calculated as number of LMs divided by Participant-Year, multiplied by 1000. Lymphoproliferative: medical condition characterized by the dysfunction of the immune system often resulting in excessive production of lymphocytes. LMs included lymphoma, myeloma, and leukemia. Adverse outcome was defined as 'lymphoproliferative malignancy' in the field \[lymphopro\] labeled by BSRBR.
Primary	Crude Incidence Rate of Serious Infections	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of serious infections divided by Participant-Year, multiplied by 1000. Serious infections included those infections which required intravenous antibiotics, hospitalization, or resulted in death. Adverse outcome was defined as 'serious infection' in the field \[serinf\] labeled by BSRBR.
Primary	Crude Incidence Rate of Other Serious Adverse Events	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of other serious adverse events divided by Participant-Year, multiplied by 1000. Other serious adverse events were based on classifications assigned by the BSRBR and included cardiac serious adverse events (SAEs), central nervous system SAEs, and nonmalignant hematological SAEs.
Primary	Crude Incidence Rate of All-Cause Mortality	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Participant-Year estimated by calculating all of the years that participants in a study were followed (number of evaluable participants multiplied by total follow-up in years). Crude (unadjusted) incidence rate calculated as number of deaths divided by Participant-Year, multiplied by 1000. Death was recorded in the adverse outcomes table and in the consultant follow-up table. Where multiple events described death for the same participant, date of death was taken as per the earliest record.
Secondary	Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Participants who switched from etanercept to either DMARDs or alternative biologic drug are reported.
Secondary	Time on Etanercept Therapy	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Time on etanercept therapy was calculated by Kaplan-Meier survival analysis.
Secondary	Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline	Baseline	DAS28 calculated from the number of swollen joints (SJC) and tender joints (TJC) using the 28 joints count, the serological markers of inflammation (erythrocyte sedimentation rate \[ESR, millimeter per hour\] or C-reactive protein \[CRP, milligram per liter\]) and patient's general health assessment (recorded on a Visual Analog Scale \[VAS\] of 0 millimeter \[mm\]-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity.
Secondary	Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5	Baseline, Year 1, 2, 3, 4, 5	DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity.
Secondary	Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)	Year 1, 2, 3, 4, 5	DAS28 calculated from SJC and TJC using the 28 joints count, the serological markers of inflammation (ESR \[millimeter per hour\] or CRP \[milligram per liter\]) and patient's general health assessment (recorded on a VAS scale of 0 mm-100 mm). DAS28 \<=1.6 = remission, DAS28 \<=2.4 = low disease activity, DAS28 \>=3.2 to 5.1 = moderate disease activity, DAS28 \>5.1 = severe disease activity.

1 to 10 of 15Source ClinicalTrials.gov

See all 15 registered outcomes

Outcomes15

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Crude Incidence Rate of Malignancy	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.	events per 1000 participant-years	NUMBER
PRIMARY	Crude Incidence Rate of Lymphoproliferative Malignancy (LM)	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.	events per 1000 participant-years	NUMBER
PRIMARY	Crude Incidence Rate of Serious Infections	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.	events per 1000 participant-years	NUMBER
PRIMARY	Crude Incidence Rate of Other Serious Adverse Events	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.	events per 1000 participant-years	NUMBER
PRIMARY	Crude Incidence Rate of All-Cause Mortality	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Safety analysis population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.	events per 1000 participant-years	NUMBER
SECONDARY	Percentage of Participants Who Switched to Other Therapy Following Etanercept Discontinuation	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	Full Analysis set (FAS) population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.	percentage of participants	NUMBER
SECONDARY	Time on Etanercept Therapy	Baseline up to last follow-up, assessed every 6 month for first 3 years and thereafter annually up to 10 years	FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration. Only participants treated with ETN were to be analyzed for this outcome measure.	years	MEDIAN
SECONDARY	Disease Activity Score Based on 28-Joints Count (DAS28) at Baseline	Baseline	FAS population included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of one consultant follow-up after baseline registration.	units on a scale	MEAN
SECONDARY	Change From Baseline in Disease Activity Score Based on 28-Joints Count (DAS28) at Year 1, 2, 3, 4, and 5	Baseline, Year 1, 2, 3, 4, 5	FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With Remission and Low Disease Activity as Assessed by Disease Activity Score Based on 28-Joints Count (DAS28)	Year 1, 2, 3, 4, 5	FAS included all participants treated with ETN or nbDMARDs who had a physician diagnosis of rheumatoid arthritis and a minimum of 1 consultant follow-up after baseline registration. N (number of participants analyzed): participants evaluable for this measure, n: participants evaluable for specified time-points for each treatment arm, respectively.	percentage of participants	NUMBER

1 to 10 of 15Source ClinicalTrials.gov

See all 15 outcomes

Results by group63

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Units
Crude Incidence Rate of Malignancy	Etanercept	14.7	events per 1000 participant-years
Crude Incidence Rate of Malignancy	nbDMARDs	23.9	events per 1000 participant-years
Crude Incidence Rate of Lymphoproliferative Malignancy (LM)	Etanercept	1.1	events per 1000 participant-years
Crude Incidence Rate of Lymphoproliferative Malignancy (LM)	nbDMARDs	2.6	events per 1000 participant-years
Crude Incidence Rate of Serious Infections	Etanercept	35.1	events per 1000 participant-years
Crude Incidence Rate of Serious Infections	nbDMARDs	36.2	events per 1000 participant-years
Crude Incidence Rate of Other Serious Adverse Events	Etanercept	20.3	events per 1000 participant-years
Crude Incidence Rate of Other Serious Adverse Events	nbDMARDs	29.6	events per 1000 participant-years
Crude Incidence Rate of All-Cause Mortality	Etanercept	12.0	events per 1000 participant-years
Crude Incidence Rate of All-Cause Mortality	nbDMARDs	20.1	events per 1000 participant-years

1 to 10 of 63Source ClinicalTrials.gov

See all 63 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Etanercept	3,529
Overall Study	STARTED	nbDMARDs	2,864
Overall Study	COMPLETED	Etanercept	2,691
Overall Study	COMPLETED	nbDMARDs	1,993
Overall Study	NOT COMPLETED	Etanercept	838
Overall Study	NOT COMPLETED	nbDMARDs	871

Source ClinicalTrials.gov

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
serious	Pneumonia	Infections and infestations	Etanercept	205	3,529
serious	Pneumonia	Infections and infestations	nbDMARDs	225	2,864
serious	Septicaemia	Infections and infestations	Etanercept	34	3,529
serious	Septicaemia	Infections and infestations	nbDMARDs	28	2,864
serious	Bone/Joint infection	Infections and infestations	Etanercept	83	3,529
serious	Bone/Joint infection	Infections and infestations	nbDMARDs	31	2,864
serious	Other serious infection	Infections and infestations	Etanercept	314	3,529
serious	Other serious infection	Infections and infestations	nbDMARDs	171	2,864
serious	Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Etanercept	11	3,529
serious	Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	nbDMARDs	18	2,864

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Etanercept
Total, all-cause mortality	nbDMARDs
Total, other adverse events	Etanercept	0	0
Total, other adverse events	nbDMARDs	0	0
Total, serious adverse events	Etanercept	944	3,529
Total, serious adverse events	nbDMARDs	744	2,864

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Etanercept vs nbDMARDs: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01646385

GET https://conductscience.org/api/trials/v1/NCT01646385/results?page=2

API reference For AI assistants