A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Participants With Rheumatoid Arthritis (MK-8457-010 AM3)



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:August 2012
End Date:May 2015
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects With Active Rheumatoid Arthritis and an Inadequate Response or Intolerance for Anti-TNF-α Therapy


The purpose of this study is to assess the safety and efficacy of MK-8457 in participants
with active rheumatoid arthritis (RA) and an inadequate response or intolerance to
anti-TNF-α therapy. The primary hypothesis of this study is that among participants with
active RA, MK-8457 100 mg BID will be superior to

placebo as measured by the proportion of participants who achieve American College of
Rheumatology 20 (ACR20) response after 12 weeks of treatment.


This study consists of a 24-week base study in which participants will receive MK-8457 100
mg twice daily or matching placebo, and a 76-week safety extension in which participants
will received MK-8457 100 mg twice daily.

Country-Specific Amendments: Amendments 1 and 2 (Brazil); Amendment 3 (Sweden)

Inclusion Criteria:

- Diagnosis of rheumatoid arthritis for at least 6 months prior to screening

- Active rheumatoid arthritis as defined by the presence of >= 6 swollen joints (of 66
count) and >= 6 tender joints (of 68 joint count)

- C-reactive protein blood level >0.9 mg/dL

- Anti-citrullinated protein antibody positive and/or rheumatoid factor positive at
screening

- American College of Rheumatology Functional Class I, II, or III

- Received methotrexate for a minimum of 3 months prior to screening with a regionally
appropriate stable weekly dose for at least 4 weeks prior to screening. The dose of
methotrexate must remain stable through Week 24 of the study.

- Failed treatment with 1 or 2 anti-tumor necrosis factor alpha (anti-TNF-α) therapies
or was intolerant to anti-TNF-α therapy prior to screening

- If using non-steroidal anti-inflammatory drugs or other analgesics, participant must
be on a stable dose

- No history of either untreated latent or active tuberculosis prior to baseline

- Participants of reproductive potential must agree to remain abstinent or use 2
acceptable methods of birth control

Exclusion Criteria:

- Presence of inflammatory disease other than rheumatoid arthritis, including but not
limited to psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus,
or Lyme disease

- Hospitalization due to an acute cardiovascular event, cardiovascular illness, or
cardiovascular surgery within 6 months of screening

- Participant has a transplanted organ, excluding corneal transplant, performed > 3
months prior to the first dose of trial medication

- History of, or current ongoing ,chronic or recurrent infectious disease

- Positive hepatitis B surface antigen or hepatitis C test result

- Human immunodeficiency virus positive

- User of recreational or illicit drugs or has had a history (within the previous 2
years) of drug or alcohol abuse or dependence

- Prior exposure to fostamatinib or other spleen tyrosine kinase inhibitors

- Prior exposure to 3 or more anti-TNF therapeutic agents

- Prior exposure to any biological agents other than anti-TNF therapeutic agents

- Currently participating in another interventional clinical trial or has participated
in an interventional clinical trial within 4 weeks prior to screening
We found this trial at
13
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