A Multiple Dose Trial of NNC 0151-0000-0000 in Subjects With Rheumatoid Arthritis

Novo Nordisk

Status and phase: Completed; Phase 2

Conditions: Inflammation; Rheumatoid Arthritis

Treatments: Drug: NNC 0151-0000-0000; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01223911

2009-011791-30 (EudraCT Number)

U1111-1116-2430 (Other Identifier)

NN8209-3607

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability and pharmacokinetics (at which rate the drug is eliminated from the body) of NNC 151-0000-0000 in subjects with rheumatoid arthritis (RA).

Enrollment: 34 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• CZ: Age between 18 and 65 years (both inclusive)
• A diagnosis of rheumatoid arthritis of at least three months before entry in trial
• Active rheumatoid arthritis (RA)
• Subjects are on stable doses of methotrexate (up to and including 25 mg/week) for at least 4 weeks before trial drug administration

Exclusion criteria

• Known or suspected allergy to trial product or related products
• Body mass index (BMI) less than 18.0 or more than 38.0 kg/m2 (inclusive)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: NNC 0151-0000-0000

B

Placebo Comparator group

Treatment:

Drug: placebo