Brodalumab (AMG 827) in Rheumatoid Arthritis (RA) Participants With Inadequate Response to Methotrexate
NCT ID: NCT00950989
Last Updated: 2021-12-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
252 participants
INTERVENTIONAL
2009-12-30
2011-02-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Placebo on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
Placebo
3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10
Methotrexate
Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.
folic acid
at least 5 mg per week
Brodalumab 70 mg
70 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
Brodalumab
3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10
Methotrexate
Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.
folic acid
at least 5 mg per week
Brodalumab 140 mg
140 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexateand folic acid supplementation (at least 5 mg per week).
Brodalumab
3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10
Methotrexate
Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.
folic acid
at least 5 mg per week
Brodalumab 210 mg
210 mg brodalumab on day 1 and weeks 1, 2, 4, 6, 8, and 10 for a total of 7 doses plus a stable weekly dose of methotrexate and folic acid supplementation (at least 5 mg per week).
Brodalumab
3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10
Methotrexate
Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.
folic acid
at least 5 mg per week
Interventions
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Brodalumab
3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10
Placebo
3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10
Methotrexate
Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.
folic acid
at least 5 mg per week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Current RA defined as ≥ 6 swollen joints (out of 66 joints examined) and ≥ 8 tender/painful joints (out of 68 joints examined) at screening and baseline (swollen and tender/painful joint count must not include distal interphalangeal joints) and at least 1 of the following at screening: Erythrocyte sedimentation rate ≥ 28 mm or C-reactive protein \> 15 mg/L
* At least 1 of the following at screening: Rheumatoid factor positive or Anti-cyclic citrullinated peptide antibody positive
* Currently taking methotrexate for ≥ 12 weeks and on a stable dose of methotrexate at 15 to 25 mg weekly for ≥ 4 weeks at day -1.
Exclusion Criteria
* Class IV RA
* Felty's syndrome
* Presence of serious infection
* Significant concurrent medical conditions
* Pregnant or breast feeding
* Significant Laboratory abnormalities
* Any disease-modifying anti-rheumatic drug (DMARD) other than methotrexate within 28 days
* Leflunomide or live vaccines within 3 months
* Previous use of any experimental or commercially available biologic DMARD
18 Years
70 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Countries
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References
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Pavelka K, Chon Y, Newmark R, Lin SL, Baumgartner S, Erondu N. A study to evaluate the safety, tolerability, and efficacy of brodalumab in subjects with rheumatoid arthritis and an inadequate response to methotrexate. J Rheumatol. 2015 Jun;42(6):912-9. doi: 10.3899/jrheum.141271. Epub 2015 Apr 15.
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20090061
Identifier Type: -
Identifier Source: org_study_id