You are here

A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

Last updated on March 22, 2018

FOR MORE INFORMATION
Study Location
ArthroCare, Arthritis Care & Research P.C.
Gilbert, Arizona, 85234 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4
months.

- At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening
and baseline.

- Hs-CRP equal or greater than 8 mg/L.

- Must have received methotrexate for at least 12 weeks and been on a stable dose for
at least 4 weeks prior to the first study dose.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Evidence of untreated or inadequately treated latent or active TB.

- Evidence of uncontrolled, clinically significant diseases, including moderate or
severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.

- History of infection requiring hospitalization or parenteral antimicrobial therapy
within 6 months prior to first dose of study drug.

- May have received no more than 2 doses of one biologic therapy (other than adalimumab
or lymphocyte depleting therapy).

- Any second DMARD must be washed out prior to the first study dose.

NCT02480153
Pfizer
Completed
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Psoriatic Arthritis
NCT01976364
All Genders
18+
Years
Multiple Sites
Arthritis Juvenile Idiopathic
NCT03000439
All Genders
2+
Years
Multiple Sites
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
A Phase 3 Randomized, Double-blind Study Assessing The Efficacy And Safety Of Pf-06410293 And Adalimumab In Combination With Methotrexate In Subjects With Moderately To Severely Active Rheumatoid Arthritis Who Have Had An Inadequate Response To Methotrexate
The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab in combination with methotrexate in subjects with moderately to severly active rheumatoid arthritis who have had an inadequate response to methotrexate.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Biological: PF-06410293
    PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
    Other Name: Adalimumab-Pfizer
  • Biological: Adalimumab
    Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
    Other Name: Adalimumab-European Union, Humira
  • Experimental: PF-06410293
    Intervention: Biological: PF-06410293
  • Active Comparator: Adalimumab
    Intervention: Biological: Adalimumab
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
597
December 6, 2017
August 31, 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4 months.
  • At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening and baseline.
  • Hs-CRP equal or greater than 8 mg/L.
  • Must have received methotrexate for at least 12 weeks and been on a stable dose for at least 4 weeks prior to the first study dose.

Exclusion Criteria:

  • Evidence of untreated or inadequately treated latent or active TB.
  • Evidence of uncontrolled, clinically significant diseases, including moderate or severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.
  • History of infection requiring hospitalization or parenteral antimicrobial therapy within 6 months prior to first dose of study drug.
  • May have received no more than 2 doses of one biologic therapy (other than adalimumab or lymphocyte depleting therapy).
  • Any second DMARD must be washed out prior to the first study dose.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Brazil,   Bulgaria,   Colombia,   Czechia,   Estonia,   Georgia,   Germany,   Hungary,   Japan,   Korea, Republic of,   Lithuania,   Mexico,   New Zealand,   Peru,   Poland,   Russian Federation,   Serbia,   South Africa,   Spain,   Taiwan,   Ukraine,   United Kingdom,   United States
Canada,   Czech Republic
 
NCT02480153
B5381002
B5381002, REFLECTIONS B538-02
2014-000352-29 ( EudraCT Number )
ADALIMUMAB ( Other Identifier: Alias Study Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
September 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now