A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis

• Sponsor: Novo Nordisk A/S (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01647451
• Collaborator: (none)
• Enrollment: 62
• Locations: 33
• Arms: 2
• Duration (Months): 11
• Patients Per Site: 1.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This trial is conducted in Europe. The aim of the trial is to evaluate the change in disease activity following intravenous (i.v.) administration of two doses of NNC0114-0006 compared to placebo in subjects with active rheumatoid arthritis (RA) on background methotrexate (MTX) therapy.

Condition or Disease	Intervention/Treatment	Phase
Inflammation; Rheumatoid Arthritis	Drug: NNC0114-0006; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Aug 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Active	Drug: NNC0114-0006; Two i.v. (intravenous) doses administered 6 weeks apart.
Placebo Comparator: Placebo	Drug: placebo; Two i.v. (intravenous) doses administered 6 weeks apart.

Outcome Measures

Primary Outcome Measures

1. Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP) [Week 0, week 12]

Secondary Outcome Measures

1. ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [Week 12]

2. Incidence of adverse events (AEs) [Up to week 24]

3. Incidence of antibodies against NNC0114-0006 [Up to Week 24]

4. Terminal serum half-life (t½) [After second dose administration at week 6]

5. Change in serum levels of total interleukin-21 (IL-21) [Up to week 12]

6. Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI) [Week 0, week 12]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• A diagnosis of RA meeting the 2010 ACR (American College of Rheumatology) classification criteria, obtained at least 6 months prior to dosing with the trial product. (If the diagnosis was made prior to 2010, a diagnosis meeting the 1987 ACR classification criteria is acceptable)

• Active RA characterised by DAS28-CRP (disease activity score based on 28 joints and c-reactive protein) equal to or above 4.5 and at least five tender and five swollen joints (can be the same joints) of the 28 joint count

• Concomitant treatment with MTX above or equal to 15 mg/week for at least 4 months prior to screening, with stable dose of between or equal to 15 mg/week and 25 mg/week for at least 6 weeks prior to screening (MTX doses between 7.5 and 12.5 mg/week are allowed, if patient had intolerance to 15 mg/week)

• Biologic naïve subjects or subjects having been treated with biologics for RA (biologic experienced) provided they meet one of the following criteria: a. Reason for discontinuation of biologic therapy was intolerance (e.g., unable to receive recommended doses or achieve adequate treatment duration because of drug related side effects), b. Discontinued biologic therapy for other reasons than lack of efficacy (primary or secondary failure) or intolerance (e.g., drug holiday)

Exclusion Criteria:

• Body mass index (BMI) below or equal to 18.0 or above or equal to 38.0 kg/m^2

• Subjects with rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA (including but not limited to vasculitis, pulmonary fibrosis, or Felty's syndrome). Subjects with secondary Sjögren's syndrome or stable hypothyroidism are eligible

• Any active or ongoing bacterial infections within 4 weeks prior to randomisation, unless treated and resolved with appropriate therapy (e.g., simple urinary tract infection)

• Any history of recurrent infections or conditions predisposing to chronic infections (e.g., bronchiectasis, chronic osteomyelitis)

• History of severe systemic fungal infection within the past 12 months prior to screening unless treated and resolved with appropriate therapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novo Nordisk Investigational Site	Plovdiv		Bulgaria	4002
2	Novo Nordisk Investigational Site	Sevlievo		Bulgaria	5400
3	Novo Nordisk Investigational Site	Sofia		Bulgaria	1233
4	Novo Nordisk Investigational Site	Sofia		Bulgaria	1606
5	Novo Nordisk Investigational Site	Sofia		Bulgaria	1612
6	Novo Nordisk Investigational Site	Budapest		Hungary	1036
7	Novo Nordisk Investigational Site	Debrecen		Hungary	4032
8	Novo Nordisk Investigational Site	Debrecen		Hungary	4043
9	Novo Nordisk Investigational Site	Szikszó		Hungary	3800
10	Novo Nordisk Investigational Site	Veszprém		Hungary	8200
11	Novo Nordisk Investigational Site	Riga		Latvia	1038
12	Novo Nordisk Investigational Site	Bialystok		Poland	15-351
13	Novo Nordisk Investigational Site	Bydgoszcz		Poland	85-168
14	Novo Nordisk Investigational Site	Bytom		Poland	41-902
15	Novo Nordisk Investigational Site	Elblag		Poland	82-300
16	Novo Nordisk Investigational Site	Katowice		Poland	40-954
17	Novo Nordisk Investigational Site	Poznan		Poland	60-218
18	Novo Nordisk Investigational Site	Warszawa		Poland	02-256
19	Novo Nordisk Investigational Site	Kazan		Russian Federation	420103
20	Novo Nordisk Investigational Site	Kursk		Russian Federation	305007
21	Novo Nordisk Investigational Site	Moscow		Russian Federation	119991
22	Novo Nordisk Investigational Site	Skt Petersburg		Russian Federation	194044
23	Novo Nordisk Investigational Site	Skt Petersburg		Russian Federation	196084
24	Novo Nordisk Investigational Site	Skt. Petersburg		Russian Federation	191025
25	Novo Nordisk Investigational Site	Skt. Petersburg		Russian Federation	191186
26	Novo Nordisk Investigational Site	Yaroslavl		Russian Federation	150051
27	Novo Nordisk Investigational Site	Belgrade		Serbia	11000
28	Novo Nordisk Investigational Site	Belgrade		Serbia	11080
29	Novo Nordisk Investigational Site	Niska Banja		Serbia	18205
30	Novo Nordisk Investigational Site	A Coruña		Spain	15006
31	Novo Nordisk Investigational Site	Barcelona		Spain	08036
32	Novo Nordisk Investigational Site	Elche		Spain	3203
33	Novo Nordisk Investigational Site	Sevilla		Spain	41013

Sponsors and Collaborators

• Novo Nordisk A/S

Investigators

• Study Director: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical Trials at Novo Nordisk

Publications

None provided.

• Responsible Party: Novo Nordisk A/S
• ClinicalTrials.gov Identifier: NCT01647451
• Other Study ID Numbers: NN8828-3842; 2011-005376-42; U1111-1125-6552
• First Posted: Jul 23, 2012
• Last Update Posted: Feb 7, 2017
• Last Verified: Feb 1, 2017

• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation

Study Results

No Results Posted as of Feb 7, 2017