Recruitment

Recruitment Status
Completed
Estimated Enrollment
498

Inclusion Criterias

Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months but not exceeding 15 years prior to Screening
Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product
...
Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months but not exceeding 15 years prior to Screening
Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product
Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL

Exclusion Criterias

History of demyelinating disorders.
History of congestive heart failure
Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4
...
History of demyelinating disorders.
History of congestive heart failure
Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4
Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
Have a current diagnosis of active tuberculosis
Other inflammatory or rheumatic diseases.
Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
History of lymphoproliferative disease including lymphoma.
History of any malignancy within the previous 5 years prior to Screening

Summary

Conditions
Rheumatoid Arthritis
Type
Interventional
Phase
Phase 3
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 75 years
Gender
Both males and females

Inclusion Criterias

Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months but not exceeding 15 years prior to Screening
Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product
...
Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months but not exceeding 15 years prior to Screening
Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product
Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL

Exclusion Criterias

History of demyelinating disorders.
History of congestive heart failure
Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4
...
History of demyelinating disorders.
History of congestive heart failure
Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4
Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
Have a current diagnosis of active tuberculosis
Other inflammatory or rheumatic diseases.
Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
History of lymphoproliferative disease including lymphoma.
History of any malignancy within the previous 5 years prior to Screening

Locations

Kielce
Southampton, Hampshire
Kielce
Southampton, Hampshire

Tracking Information

NCT #
NCT01895309
Collaborators
Not Provided
Investigators
  • Principal Investigator: Jiri Vencovsky, M.D., Ph.D. Charles University, Czech Republic
  • Jiri Vencovsky, M.D., Ph.D. Charles University, Czech Republic