NCT00950989

Brief Summary

Study in participants with RA who have an inadequate response to methotrexate.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
252

participants targeted

Target at P75+ for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Dec 2009

Shorter than P25 for phase_2 rheumatoid-arthritis

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

December 30, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2011

Completed
10.9 years until next milestone

Results Posted

Study results publicly available

December 21, 2021

Completed
Last Updated

December 21, 2021

Status Verified

November 1, 2021

Enrollment Period

1.1 years

First QC Date

July 30, 2009

Results QC Date

November 22, 2021

Last Update Submit

November 22, 2021

Conditions

Rheumatoid Arthritis

Keywords

Autoimmune DiseasesMusculoskeletal DiseasesJoint DiseasesArthritisConnective Tissue DiseasesArthritis, RheumatoidRheumatic Diseases

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With an American College of Rheumatology 50% (ACR50) Response at Week 12

    A positive ACR50 response is defined if the following 3 criteria for improvement from baseline were met: * 50% improvement in 68 tender joint count; * 50% improvement in 66 swollen joint count; and * 50% improvement in at least 3 of the 5 following parameters: * Patient's assessment of joint pain (measured on a 100 mm visual analog scale \[VAS\]), * Patient's global assessment of disease activity (measured on a 0-10 Likert scale), * Physician's global assessment of disease activity (measured on a 0-10 Likert scale), * Patient's self assessment of disability (Health Assessment Questionnaire - Disability Index \[HAQ-DI\]), * Acute phase reactant: erythrocyte sedimentation rate (ESR) or C-Reactive Protein (CRP), whichever has bigger improvement.

    Baseline, week 12

Secondary Outcomes (7)

  • Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12

    Baseline, Week 12

  • Percentage of Participants With an American College of Rheumatology 70% (ACR70) Response at Week 12

    Baseline, week 12

  • Disease Activity Score 28 (DAS28) at Week 12

    Week 12

  • Number of Participants With Treatment Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs Leading to Discontinuation

    From first dose of study drug until the end of study; median (min, max) duration was 113 days (8, 132).

  • Pharmacokinetics (PK) of Brodalumab: Maximum Observed Concentration (Cmax)

    Week 8: Day 59-Day 61 (44-100 hours post-dose), Day 64 (160-176 hours post-dose), Week 10: pre-dose

  • +2 more secondary outcomes

Study Arms (4)

Placebo

PLACEBO COMPARATOR

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).

Drug: PlaceboDrug: MethotrexateDietary Supplement: folic acid

Brodalumab 70 mg

EXPERIMENTAL

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).

Drug: BrodalumabDrug: MethotrexateDietary Supplement: folic acid

Brodalumab 140 mg

EXPERIMENTAL

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).

Drug: BrodalumabDrug: MethotrexateDietary Supplement: folic acid

Brodalumab 210 mg

PLACEBO COMPARATOR

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).

Drug: BrodalumabDrug: MethotrexateDietary Supplement: folic acid

Interventions

BrodalumabDRUG

3 single subcutaneous (SC) injections at day 1 and weeks 1, 2, 4, 6, 8, and 10

Also known as: AMG 827
Brodalumab 140 mgBrodalumab 210 mgBrodalumab 70 mg
PlaceboDRUG

3 single SC injections at day 1 and weeks 1, 2, 4, 6, 8, and 10

Placebo
MethotrexateDRUG

Two methotrexate dose adjustments were allowed in the event of methotrexate toxicity, however, doses \< 7.5 mg/week necessitated discontinuation from study.

Brodalumab 140 mgBrodalumab 210 mgBrodalumab 70 mgPlacebo
folic acidDIETARY_SUPPLEMENT

at least 5 mg per week

Brodalumab 140 mgBrodalumab 210 mgBrodalumab 70 mgPlacebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active RA for least 6 months
  • 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.

You may not qualify if:

  • Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25877498BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidAutoimmune DiseasesMusculoskeletal DiseasesJoint DiseasesArthritisConnective Tissue DiseasesRheumatic Diseases

Interventions

brodalumabMethotrexateFolic Acid

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
medinfo@amgen.com
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2009

First Posted

August 3, 2009

Study Start

December 30, 2009

Primary Completion

February 11, 2011

Study Completion

February 11, 2011

Last Updated

December 21, 2021

Results First Posted

December 21, 2021

Record last verified: 2021-11