A Randomised, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0114-0006 in Subjects With Active Rheumatoid Arthritis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01647451 |
Recruitment Status :
Completed
First Posted : July 23, 2012
Last Update Posted : February 7, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammation Rheumatoid Arthritis | Drug: NNC0114-0006 Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
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 : | September 2012 |
Actual Primary Completion Date : | August 2013 |
Actual Study Completion Date : | August 2013 |

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. |
- Change in disease activity score based on 28 joints and c-reactive protein (DAS28-CRP) [ Time Frame: Week 0, week 12 ]
- ACR20/50/70 (20%, 50% or 70% improvement of ACR (American College of Rheumatology) score from baseline) [ Time Frame: Week 12 ]
- Incidence of adverse events (AEs) [ Time Frame: Up to week 24 ]
- Incidence of antibodies against NNC0114-0006 [ Time Frame: Up to Week 24 ]
- Terminal serum half-life (t½) [ Time Frame: After second dose administration at week 6 ]
- Change in serum levels of total interleukin-21 (IL-21) [ Time Frame: Up to week 12 ]
- Change in Health Assessment Questionnaire - Disability Index score (HAQ-DI) [ Time Frame: Week 0, week 12 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01647451
Bulgaria | |
Novo Nordisk Investigational Site | |
Plovdiv, Bulgaria, 4002 | |
Novo Nordisk Investigational Site | |
Sevlievo, Bulgaria, 5400 | |
Novo Nordisk Investigational Site | |
Sofia, Bulgaria, 1233 | |
Novo Nordisk Investigational Site | |
Sofia, Bulgaria, 1606 | |
Novo Nordisk Investigational Site | |
Sofia, Bulgaria, 1612 | |
Hungary | |
Novo Nordisk Investigational Site | |
Budapest, Hungary, 1036 | |
Novo Nordisk Investigational Site | |
Debrecen, Hungary, 4032 | |
Novo Nordisk Investigational Site | |
Debrecen, Hungary, 4043 | |
Novo Nordisk Investigational Site | |
Szikszó, Hungary, 3800 | |
Novo Nordisk Investigational Site | |
Veszprém, Hungary, 8200 | |
Latvia | |
Novo Nordisk Investigational Site | |
Riga, Latvia, 1038 | |
Poland | |
Novo Nordisk Investigational Site | |
Bialystok, Poland, 15-351 | |
Novo Nordisk Investigational Site | |
Bydgoszcz, Poland, 85-168 | |
Novo Nordisk Investigational Site | |
Bytom, Poland, 41-902 | |
Novo Nordisk Investigational Site | |
Elblag, Poland, 82-300 | |
Novo Nordisk Investigational Site | |
Katowice, Poland, 40-954 | |
Novo Nordisk Investigational Site | |
Poznan, Poland, 60-218 | |
Novo Nordisk Investigational Site | |
Warszawa, Poland, 02-256 | |
Russian Federation | |
Novo Nordisk Investigational Site | |
Kazan, Russian Federation, 420103 | |
Novo Nordisk Investigational Site | |
Kursk, Russian Federation, 305007 | |
Novo Nordisk Investigational Site | |
Moscow, Russian Federation, 119991 | |
Novo Nordisk Investigational Site | |
Skt Petersburg, Russian Federation, 194044 | |
Novo Nordisk Investigational Site | |
Skt Petersburg, Russian Federation, 196084 | |
Novo Nordisk Investigational Site | |
Skt. Petersburg, Russian Federation, 191025 | |
Novo Nordisk Investigational Site | |
Skt. Petersburg, Russian Federation, 191186 | |
Novo Nordisk Investigational Site | |
Yaroslavl, Russian Federation, 150051 | |
Serbia | |
Novo Nordisk Investigational Site | |
Belgrade, Serbia, 11000 | |
Novo Nordisk Investigational Site | |
Belgrade, Serbia, 11080 | |
Novo Nordisk Investigational Site | |
Niska Banja, Serbia, 18205 | |
Spain | |
Novo Nordisk Investigational Site | |
A Coruña, Spain, 15006 | |
Novo Nordisk Investigational Site | |
Barcelona, Spain, 08036 | |
Novo Nordisk Investigational Site | |
Elche, Spain, 3203 | |
Novo Nordisk Investigational Site | |
Sevilla, Spain, 41013 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Publications of Results:
Responsible Party: | Novo Nordisk A/S |
ClinicalTrials.gov Identifier: | NCT01647451 |
Other Study ID Numbers: |
NN8828-3842 2011-005376-42 ( EudraCT Number ) U1111-1125-6552 ( Other Identifier: WHO ) |
First Posted: | July 23, 2012 Key Record Dates |
Last Update Posted: | February 7, 2017 |
Last Verified: | February 2017 |
Arthritis Arthritis, Rheumatoid Inflammation Joint Diseases Musculoskeletal Diseases |
Pathologic Processes Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |