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Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

Primary Purpose

Arthritis, Rheumatoid

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

etanercept

About this trial

This is an interventional treatment trial for Arthritis, Rheumatoid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints.
Either the patient or a designee must be capable of administering the subcutaneous injection of study drug.

Exclusion Criteria:

Prior treatment with etanercept.
Presence of active infection or active or untreated tuberculosis.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ETN 50mg QW

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12

Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24

Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment

Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

Secondary Outcome Measures

Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment

Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was 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. Treatment-emergent were events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

Number of Participants With Investigator-Identified Serious Infections

Infection was considered as serious by investigator for any of the following outcomes: death; life-threatening; required initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity or congenital anomaly/birth defect.

Number of Participants With Injection Site Reactions

Injection site reactions included injection site erythema, swelling, pain and warmth.

Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities

Laboratory abnormalities(national cancer institute toxicity criteria version 4.0),Grade 3:neutrophil (greater than or equal to[>=]0.5,less than[<]1.0 10^9/L),lymphocyte (<0.5 10^9/L),hemoglobin (Hb) (<80,>=65 gram per liter [g/L]),platelet(<50.0,>=25.0 10^9/L),white blood count(WBC) (<2.0, >=1.0 10^9/L);alkaline phosphatase (AP),aspartate aminotransferase(AST),alanine aminotransferase(ALT) (greater than[>]5.0*upper range [UR], <=20.0*UR unit per liter[U/L]);bilirubin(>1.5*UR, less than or equal to[<=]3.0*UR micromole per liter[mcmol/L]);creatinine(>3.0*UR, <=6.0*UR mcmol/L);albumin (<20.0 g/L),urea(>3.0*UR, <=4.0*UR g/L);potassium (K)-high,low (>6.0,<=7.0or<3.0,>=2.5 mcmol/L); sodium(Na)-high,low(>155, <=160 or <130, >=120 mcmol/L)and Grade 4: neutrophil(<0.5 10^9/L),Hb (<65 g/L);platelet (<25.0 10^9/L); WBC(<1.0 10^9/L);AP,AST,ALT(>20.0*UR U/L);bilirubin(>3.0*UR mcmol/L);creatinine (>6.0*UR mcmol/L);urea (>4.0*UR g/L);K-high,low (>7.0or<2.5 mcmol/L);Na-high, low (>160or<120 mcmol/L).

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

ACR20 responder: participants with 20 percent (%) improvement in tender and swollen 28-joint counts and 20% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR20 response were reported.

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

ACR50 responder: participants with 50% improvement in tender and swollen 28-joint counts and 50% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR50 response were reported.

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

ACR70 responder: participants with 70% improvement in tender and swollen 28-joint counts and 70% improvement in at least 3 of the 5 measures: participant global assessment of arthritis (PtGA), physician global assessment of arthritis (PGA), participant pain visual analogue scale (Pain-VAS), health assessment questionnaire-disability index (HAQ-DI) and C-reactive protein. PtGA: participant assessed overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. PGA: physician judged participant's overall disease activity, score: 0 (no arthritis) to 10 (extreme arthritis), higher score=more arthritis. Pain-VAS: participant assessed arthritis pain by 100 millimeter (mm) VAS, score: 0 mm (no pain) to 100 mm (extreme pain), higher score=more pain. HAQ-DI: functional disability evaluation, score: 0 (no difficulty) to 3 (extreme difficulty), higher score=more disability. Percentage of participants with ACR70 response were reported.

Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24

DAS28: measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (ESR) was calculated from number of swollen joints (SJC) and tender joints (TJC ) using the 28 joints count, erythrocyte sedimentation rate (millimeter per hour [mm/hour]) and participant's general health visual analog scale assessment (scores: 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (ESR) score: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (ESR) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.

Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24

DAS28 is a measure of disease activity in participants with rheumatoid arthritis. DAS28-4 (CRP) was calculated from the number of swollen joints and tender joints using the 28 joints count, C-Reactive protein (milligram per liter [mg/L]) and participant's general health visual analog scale assessment (scores ranging 0 mm [very well] to 100 mm [extremely bad], higher scores indicate worse health condition). Total DAS28-4 (CRP) score range: 0 (none) to 10 (extreme disease activity), higher scores indicate more disease activity. DAS28-4 (CRP) less than (<) 2.6= remission, <3.2= low disease activity, greater than or equal to (>=) 3.2 to 5.1= moderate disease activity and >5.1= high disease activity.

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24

HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each item scored on 4-point scale from 0 to 3: 0= no difficulty; 1= some difficulty; 2= much difficulty; 3= unable to do. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0 (least difficulty) and 3 (extreme difficulty), where higher scores indicate more difficulty while performing daily living activities.

Full Information

NCT ID

NCT02378506

First Posted

February 13, 2015

Last Updated

May 10, 2017

Sponsor

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT02378506

Brief Title

Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

Official Title

A Single-arm, Open-label Study To Assess The Immunogenicity, Safety, And Efficacy Of Etanercept Manufactured Using The High Capacity Process Administered To Subjects With Rheumatoid Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

April 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Open-label immunogenicity, safety and efficacy study of etanercept manufactured using the high capacity process. Descriptive results will be provided however a formal hypothesis will not be tested in this trial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis, Rheumatoid

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

188 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ETN 50mg QW

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

etanercept

Intervention Description

50mg subcutaneous, once weekly, 24 weeks

Primary Outcome Measure Information:

Title

Percentage of Participants With Positive Etanercept Anti-Drug Antibody (ADA) Status at Week 12

Description

Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

Time Frame

Week 12

Title

Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status at Week 24

Description

Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

Time Frame

Week 24

Title

Percentage of Participants With Positive Etanercept Anti-Drug Antibody Status: Throughout Study Treatment

Description

Participants who developed anti-drug antibodies after treatment with Etanercept were evaluated. Percentage of participants with positive Etanercept anti-drug antibodies were summarized.

Time Frame

Baseline up to Week 24

Secondary Outcome Measure Information:

Title

Percentage of Participants With Positive Etanercept Neutralizing Anti-Drug Antibody Status: Throughout Study Treatment

Description

Percentage of participants with positive Etanercept neutralizing anti-drug antibodies were summarized.

Time Frame

Baseline (Day 1) up to Week 24

Title

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Description

Time Frame

Baseline (Day 1) up to Week 28 (Follow-up)

Title

Number of Participants With Investigator-Identified Serious Infections

Description

Time Frame

Baseline (Day 1) up to Week 28 (Follow-up)

Title

Number of Participants With Injection Site Reactions

Description

Injection site reactions included injection site erythema, swelling, pain and warmth.

Time Frame

Baseline (Day 1) up to Week 28 (Follow-up)

Title

Number of Participants With Grade 3 and 4 Clinical Laboratory Abnormalities

Description

Time Frame

Baseline (Day 1) up to Week 28 (Follow-up)

Title

Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response

Description

Time Frame

Week 4, 12, 24

Title

Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response

Description

Time Frame

Week 4, 12, 24

Title

Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response

Description

Time Frame

Week 4, 12, 24

Title

Change From Baseline in Disease Activity Scale Based on 28 Joint Count Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) at Week 4, 12 and 24

Description

Time Frame

Baseline, Week 4, 12, 24

Title

Change From Baseline in Disease Activity Scale Based on 28 Joint Count C-Reactive Protein (4 Variables) (DAS28-4 [CRP]) at Week 4, 12 and 24

Description

Time Frame

Baseline, Week 4, 12, 24

Title

Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 4, 12 and 24

Description

Time Frame

Baseline, Week 4, 12, 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Moderate to severe active disease with presence of at least 4 tender joints and 4 swollen joints. Either the patient or a designee must be capable of administering the subcutaneous injection of study drug. Exclusion Criteria: Prior treatment with etanercept. Presence of active infection or active or untreated tuberculosis.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pfizer CT.gov Call Center

Organizational Affiliation

Pfizer

Official's Role

Study Director

Facility Information:

Facility Name

MHAT Plovdiv

City

Plovdiv

ZIP/Postal Code

4000

Country

Bulgaria

Facility Name

DCC "Aleksandrovska" EOOD

City

Sofia

ZIP/Postal Code

1431

Country

Bulgaria

Facility Name

UMHAT "Sv. Ivan Rilski" EAD, Sofia

City

Sofia

ZIP/Postal Code

1612

Country

Bulgaria

Facility Name

Medical Center - "New rehabilitation center" EOOD

City

Stara Zagora

ZIP/Postal Code

6000

Country

Bulgaria

Facility Name

Chc Rijeka

City

Rijeka

ZIP/Postal Code

51000

Country

Croatia

Facility Name

Medicinski Centar Kuna Peric

City

Zagreb

ZIP/Postal Code

10000

Country

Croatia

Facility Name

Centrum für innovative Diagnostik und Therapie

City

Frankfurt/Main

State/Province

Hessen

ZIP/Postal Code

60528

Country

Germany

Facility Name

Rheumaforschung - Studienambulanz Dr. Wassenberg

City

Ratingen

State/Province

Nordrhein-westfalen

ZIP/Postal Code

40882

Country

Germany

Facility Name

Schlosspark-Klinik, Innere Medizin II, Rheumatologie

City

Berlin

ZIP/Postal Code

14059

Country

Germany

Facility Name

Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Immunologisches Zentrum Vogelsang-Gommern GmbH

City

Vogelsang-Gommern

ZIP/Postal Code

39245

Country

Germany

Facility Name

Rheumatology Department

City

Rion Patras

State/Province

Achaia

ZIP/Postal Code

26500

Country

Greece

Facility Name

University Hospital of Heraklion

City

Heraklion

State/Province

Crete

ZIP/Postal Code

71110

Country

Greece

Facility Name

Rheumatology Unit

City

Thessaloniki

ZIP/Postal Code

56429

Country

Greece

Facility Name

Qualiclinic Kft.

City

Budapest

ZIP/Postal Code

1036

Country

Hungary

Facility Name

Pest Megyei Flor Ferenc Korhaz

City

Kistarcsa

ZIP/Postal Code

2143

Country

Hungary

Facility Name

Szabolcs-Szatmar-Bereg megyei

City

Nyiregyhaza

ZIP/Postal Code

4400

Country

Hungary

Facility Name

Krakowskie Centrum Medyczne sp. Z.O.O

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

NZOZ Lecznica MAK-MED s.c.

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

Prywatna Praktyka Lekarska Prof. UM dr hab.med. Pawel Hrycaj

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

Reumatika-Centrum Reumatologii

City

Warszawa

ZIP/Postal Code

02-691

Country

Poland

Facility Name

Institute of Rheumatology

City

Belgrade

State/Province

Beograd

ZIP/Postal Code

11000

Country

Serbia

Facility Name

Reumatologicka ambulancia

City

Bratislava

ZIP/Postal Code

841 04

Country

Slovakia

Facility Name

AAGS, s.r.o.

City

Dunajska Streda

ZIP/Postal Code

929 01

Country

Slovakia

Facility Name

Reumatologicka ambulancia, MUDr. Zuzana Cizmarikova, s.r.o.

City

Poprad

ZIP/Postal Code

058 01

Country

Slovakia

Facility Name

REUMEX s.r.o.

City

Rimavska Sobota

ZIP/Postal Code

979 01

Country

Slovakia

Facility Name

REUMA-GLOBAL s.r.o.

City

Trnava

ZIP/Postal Code

917 01

Country

Slovakia

Facility Name

Reumatologicka ambulancia

City

Zilina

ZIP/Postal Code

010 01

Country

Slovakia

Facility Name

Panorama Medical Centre

City

Panorama

State/Province

Cape Town

ZIP/Postal Code

7500

Country

South Africa

Facility Name

Wits Clinical Research CMJAH Clinical Trial Site

City

Parktown

State/Province

Johannesburg

ZIP/Postal Code

2193

Country

South Africa

Facility Name

St. Augustines Hospital

City

Durban/Berea

State/Province

Kwazulu-natal

ZIP/Postal Code

4001

Country

South Africa

12. IPD Sharing Statement

Citations:

PubMed Identifier

30451655

Citation

Polak P, Peric P, Louw I, Gaylord SM, Williams T, Becker JC, Pedersen R, Korth-Bradley J, Vlahos B. A single-arm, open-label study to assess the immunogenicity, safety, and efficacy of etanercept manufactured using the serum-free, high-capacity manufacturing process administered to patients with rheumatoid arthritis. Eur J Rheumatol. 2019 Jan;6(1):23-28. doi: 10.5152/eurjrheum.2018.18078.

Results Reference

derived

Links:

URL

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1801359&StudyName=Study%20to%20Assess%20the%20Immunogenicity%2C%20Safety%2C%20and%20Efficacy%20of%20Etanercept%20Manufactured%20Using%20the%20High%20Capacity%20Process%20Administered%20to%20Rh

Description

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Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

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Study to Assess the Immunogenicity, Safety, and Efficacy of High Capacity Process Etanercept in Rheumatoid Arthritis Subjects

Arthritis, Rheumatoid

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial