Study Conducted in Subjects With Rheumatoid Arthritis Who Have Moderate to Severe Disease Activity Despite Methotrexate Therapy With or Without Other Non Biologic Disease Modifying Antirheumatic Drugs (DMARDs)for at Least 12 Weeks Prior to Screening

Rheumatoid Arthritis Clinical Trial

Official title:

A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01578850
• Other study ID #: B1801315
• Secondary ID: 2011-005448-87B1
• Status: Completed
• Phase: Phase 4
• First received: April 12, 2012
• Last updated: May 19, 2015
• Start date: July 2012
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control Council
• Study type: Interventional

Clinical Trial Summary

To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 491
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.

2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of =10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.

Exclusion Criteria:

1. Subjects who used any of the following systemic treatments during the washout periods given below:

1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.

2. Treatment with more than 1 NSAID within 14 days at baseline.

3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.

4. Subjects will be allowed to continue the following non biologic DMARDs:

sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week 1.

5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.

2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• Etanercept
etanercept 50mg once weekly + methotrexate with or without other DMARDs
• placebo
etanercept placebo once weekly + methotrexate with or without other DMARDs

Locations

Country	Name	City	State
Brazil	CIP (Centro Internacional de Pesquisa)	Goiania	Goiás
Brazil	Research Center	Juiz de Fora
Brazil	Hospital Santa Izabel - Santa Casa de Misericórdia da Bahia	Salvador	Bahia
Brazil	CEPIC - Centro Paulista de Investigacao Clinica e Servicos Medicos LTDA	Sao Paulo	SP
China	Chinese Academy of Medical Sciences - Peking Union Medical C	Beijing
China	Guangdong General Hospital	Guangzhou	Guangdong
China	Shanghai Changhai Hospital[Rheumatology &Immunology]	Shanghai
China	Shanghai Changning District Guanghua Hospital of Traditional Chinese and Western Medicine	Shanghai
Colombia	Hospital Pablo Tobon Uribe (HPTU)	Antioquia
Colombia	Centro Integral de reumatolo[Gerencia / Representante Legal]	Barranquilla	Atlántico
Colombia	Fundacion Instituto de Reumatologia Fernando Chalem	Bogota DC	Cundinamarca
Czech Republic	Revmatologicka poradna III. Interni nefrologicka, revmatologicka a endokrinologicka klinika	Olomouc
Czech Republic	Revmatologicky ustav	Praha 2
Czech Republic	Revmatologicka ambulance	Praha 5
Czech Republic	PV-Medical s.r.o.	Zlin
Egypt	New University Hospital, Alexandria Clinical Research Center	Alexandria	Al Iskandariyah
Egypt	Ain Shams University/Al Demerdash Hospital/Diabetology Unit	Cairo
Egypt	Al Azhar University Hospital [Rheumatology]	Cairo	Al Qahirah
Hungary	Budai Irgalmasrendi Korhaz	Budapest
Hungary	Magyar Honvédség Egészségügyi Központ	Budapest
Jordan	Pharmaceutical Research Center- PRC. Jordan University of Science and Technology	Irbid
Lebanon	American University of Beirut Medical Center	Beirut
Malaysia	Queen Elizabeth Hospital	Kota Kinabalu	Sabah
Malaysia	University Malaysia Medical Centre	Kuala Lumpur
Malaysia	Hopsital Putrajaya [Medicine]	Putrajaya	Wilayah Persekutuan Putrajaya
Mexico	Centro de Investigación y Atención Integral de Durango, SC	Durango	Durango / Mexico
Mexico	Centro Medico Las Americas	Merida	Yucatan
Mexico	Centro de Alta Especialidad en Reumatología e Investigación	San Luis de Potosi	San Luis Potosí / Mexico
Mexico	Hospital Central	San Luis Potosi
Philippines	Angeles University Foundation Medical Center	Angeles City	Pampanga
Philippines	Chong Hua Hospital, Medical Arts Center	Cebu City
Philippines	De La Salle University Health Sciences Campus- Clinical Epidemiology Unit	Dasmarinas	Cavite
Philippines	UP-Philippine General Hospital, Medical Research Laboratory, Medicine Department,	Manila
Philippines	St. Luke's Mecical Center	Quezon	Manila
Qatar	Hamad Medical Corporation	Doha
Romania	Spitalul Judetean	Baia Mare	Maramure
Romania	Spitalul Clinic Judetean de Urgenta Brasov	Brasov
Romania	Spitalul Clinic de Recuperare	Iasi
Romania	Spitalul Clinic Judetean de Urgenta Targu Mures	Tg Mures
Russian Federation	LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7 (Actual address)	Kazan
Russian Federation	LLC Research Medical Complex Your Health based on City Clinical Hospital Number 7(Legal address)	Kazan
Russian Federation	Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky	Krasnoyarsk
Russian Federation	Krasnoyarsk State Medical University named after Professor V.F. Voyno-Yasenetsky,	Krasnoyarsk
Russian Federation	FSBSI "Scientific Research Institute of Rheumatology n. a. V.A. Nasonova"	Moscow
Russian Federation	LLC Institute of Medical Trials (Actual address)	St. Petersburg
South Africa	Universitas Hospital [Cardiololgy]	Bloemfontein	Free State
South Africa	Vincent Pallotti Hospital	Cape Town
South Africa	Winelands Medical Research Centre	Stellenbosch
Taiwan	Buddhist Tzu Chi General Hospital - Dalin Branch	Chia-Yi
Taiwan	China Medical University Hospital, Division of Rheumatology, Allergy and Immunology	Taichung
Taiwan	Taipei Medical University Hospital	Taipei
Taiwan	Cathay General Hospital	Taiwan	Taoyuan
Thailand	Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine,	Amphoe Mueang	Chiang Mai
Thailand	Siriraj Hospital [Rheumatology]	Bangkok
Thailand	Khon Kaen University (KKU) - Faculty of Medicine	Khon Kaen
Thailand	Songklanagarind Hospital	Songkla
Ukraine	Komunalnyi zaklad Kyivskoi oblasnoi rady "Kyivska oblasna klinichna likarnia"	Kyiv
Ukraine	Odessa Regional Clinical Hospital, Outpatient Department	Odessa
Ukraine	Republican Clinical Hospital, Department of Internal Medicine #2 of Crimean State Medical University	Simferopol	Crimea
Ukraine	Municipal Institution of Ternopil Regional Council Ternopil University Hospital	Ternopil
Ukraine	Vinnitsa Regional Clinical Hospital n.a. Pirogov, Department of Faculty Therapy of Vinnitsa NMU	Vinnitsa
United Arab Emirates	Al Baraha Hospital	Dubai

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Brazil,  China,  Colombia,  Czech Republic,  Egypt,  Hungary,  Jordan,  Lebanon,  Malaysia,  Mexico,  Philippines,  Qatar,  Romania,  Russian Federation,  South Africa,  Taiwan,  Thailand,  Ukraine,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects who remained in low disease activity at Week 52, among those who have achieved it at Week 24.		52 weeks	No
Secondary	Proportion of subjects who remained in remission at Week 52, among those who have achieved remission at Week 24.		52 weeks	No
Secondary	Proportion of subjects in LDA or remission at each visit during Period 1 and Period 2.		24 weeks, 52 weeks	No
Secondary	Change from baseline in the DAS28 score at each visit during Period 1 and Period 2.		24 weeks, 52 weeks	No
Secondary	Time-to-flare or loss of efficacy during Period 2.		52 weeks	No
Secondary	Proportion of subjects achieving European League Against Rheumatism good and or moderate responses at each visit during Period 1 and Period 2.		24 weeks, 52 weeks	No
Secondary	Proportion of subjects achieving LDA or remission at each visit during Period 1 and 2 based on CDAI and SDAI each visit during Period 1 and 2.		24 weeks, 52 weeks	No
Secondary	Change of CDAI and SDAI at each visit during Period 1 and 2.		24 weeks, 52 weeks	No
Secondary	Proportion of subjects achieving ACR 20, ACR 50, ACR 70 and ACR 90 during Period 1 and Period 2 at each visit.		24 weeks, 52 weeks	No
Secondary	Change in the tender and swollen joint counts at each visit during Period 1 and Period 2.		24 weeks, 52 weeks	No
Secondary	Change in the Physician Global Assessment at each visit during Period 1 and Period 2.		24 weeks, 52 weeks	No
Secondary	Change in the Subject Global Assessment, including morning stiffness (measured in minutes) at each visit during Period 1 and Period 2.		24 weeks, 52 weeks	No
Secondary	Change in the Subject General Health visual analog scale, and Pain VAS at each visit during Period 1 and Period 2.		24 weeks, 52 weeks	No
Secondary	Change in CRP and ESR at each visit during Period 1 and Period 2.		24 weeks, 52 weeks	No

External Links

•   To obtain contact information for a study center near you, click here.