NCT01559103

Brief Summary

Study to assess the safety and tolerability of MEDI5117 in Rheumatoid Arthritis patients

Trial Health

60
Monitor

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for phase_1 rheumatoid-arthritis

Timeline
Completed

Started May 2012

Typical duration for phase_1 rheumatoid-arthritis

Geographic Reach
3 countries

3 active sites

Status
terminated

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

March 19, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 21, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

May 31, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2014

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

1.7 years

First QC Date

March 19, 2012

Last Update Submit

February 4, 2021

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid ArthritisPhase IBiologic

Outcome Measures

Primary Outcomes (1)

  • Description of the safety profile in terms of adverse events, blood pressure, pulse, temperature, ECG (Electrocardiogram), physical examination, and safety laboratory variables.

    From Baseline up to 64 weeks

Secondary Outcomes (6)

  • Description of pharmacokinetics in terms of Maximum serum concentration (Cmax), time to Cmax (tmax), terminal rate constant(λz), terminal half-life (t1/2 λz).

    From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.

  • Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of the last quantifiable concentration [AUC(0-t)] and from zero to infinity (AUC).

    From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.

  • Description of pharmacokinetics in terms of area under the serum concentration-time curve from zero to the time of concentration at Weeks 6 and 12 [AUC(0-6w) and AUC(0 12w)].

    From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.

  • Descriptions of pharmacokinetics in terms of systemic clearance (CL), volume of distribution during terminal phase (Vz), and volume of distribution at steady state (Vdss).

    From Day 1 Predose, 2h, 12h, 24h, day 7, week 2, 3, 4, 6, 8, 12, 16, 20, 24, 32, 40, 48, 56 and week 64.

  • Description of pharmacodynamics in terms of total interleukin 6 (IL-6) and free IL-6 (exploratory) in plasma and high sensitive C-reactive protein (hs-CRP) pre and post MEDI5117 or placebo administration and their corresponding change from baseline.

    From Baseline day -1 to week 64

  • +1 more secondary outcomes

Study Arms (2)

MEDI5117

EXPERIMENTAL

Intravenous infusion administered over 60 minutes

Biological: MEDI5117

MEDI5117 Placebo

PLACEBO COMPARATOR

Intravenous infusion administered over 60 minutes

Biological: MEDI5117 Placebo

Interventions

MEDI5117BIOLOGICAL

Intravenous infusion administered over 60 minutes, will be one of the following doses: 30, 100, 300, or 600 mg

MEDI5117
MEDI5117 PlaceboBIOLOGICAL

Intravenous infusion administered over 60 minutes

MEDI5117 Placebo

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active Rheumatoid Arthritis (RA) for 6 months or more.
  • Males or nonpregnant, nonlactating femails aged 20 to 75 years, inclusive.
  • Body Mass Index (BMI) between 19 and 36 kg/m2 and weight between 50 and 145 kg, inclusive.
  • Males, unless surgically sterile, must use 2 effective methods of birth control from Day 1 through follow-up.

You may not qualify if:

  • History or presence of any clinically significant disease or disorder which has not been stable over the previous 3 months.
  • History of liver disease, bilirubin elevations, or Gilbert's Syndrome.
  • Any systematic inflammatory condition in addition to RA (polymyalgia rheumatica, giant cell arthritis, systemic lupus, gout, pyrophosphate arthropathy).
  • Current, chronic pain disorders including fibromyalgia and chronic regional pain syndromes or chronic fatigue syndromes.
  • Intramuscular steroid injection or intraarticular steroid injection within 1 month of enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Novo Nordisk Investigational Site

Overland Park, Kansas, United States

Location

Novo Nordisk Investigational Site

Berlin, Germany

Location

Novo Nordisk Investigational Site

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Clinical Transparency (dept. 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2012

First Posted

March 21, 2012

Study Start

May 31, 2012

Primary Completion

February 28, 2014

Study Completion

February 28, 2014

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will share

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

More information

Locations

US(1)GB(1)DE(1)