Study to Assess the Safety and Tolerability of MEDI5117 in Rheumatoid Arthritis Patients

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01559103
• Collaborator: (none)
• Enrollment: 39
• Locations: 3
• Arms: 2
• Actual Duration (Months): 21
• Patients Per Site: 13
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Biological: MEDI5117; Biological: MEDI5117 Placebo	Phase 1

Detailed Description

A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (anti-IL-6)

Study Design

• Study Type: Interventional
• Actual Enrollment: 39 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Double-blind, Placebo-controlled, Randomized Study in Rheumatoid Arthritis Subjects to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of MEDI5117 (Anti-IL-6)
• Actual Study Start Date: May 31, 2012
• Actual Primary Completion Date: Feb 28, 2014
• Actual Study Completion Date: Feb 28, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MEDI5117 Intravenous infusion administered over 60 minutes	Biological: MEDI5117; Intravenous infusion administered over 60 minutes, will be one of the following doses: 30, 100, 300, or 600 mg
Placebo Comparator: MEDI5117 Placebo Intravenous infusion administered over 60 minutes	Biological: MEDI5117 Placebo; Intravenous infusion administered over 60 minutes

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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.]

2. 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.]

3. 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.]

4. 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.]

5. 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]

6. Description of immunogenicity in terms of positive or negative for the presence of antidrug antibodies against MEDI5117 in blood. [From Baseline day -1 to week 64]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Overland Park	Kansas	United States
2	Novo Nordisk Investigational Site	Berlin		Germany
3	Novo Nordisk Investigational Site	Belfast		United Kingdom

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01559103
• Other Study ID Numbers: NN6018-4789; 2011-005402-29
• First Posted: Mar 21, 2012
• Last Update Posted: Feb 9, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Novo Nordisk A/S: Rheumatoid Arthritis; Phase I; Biologic
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of Feb 9, 2021