Efficacy of NNC0142-0002 in Subjects With Rheumatoid Arthritis (RA)
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ClinicalTrials.gov Identifier: NCT01181050 |
Recruitment Status :
Completed
First Posted : August 13, 2010
Results First Posted : April 28, 2014
Last Update Posted : October 3, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammation Rheumatoid Arthritis | Drug: NNC0142-0002 Drug: placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 63 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomised, Single-dose, Double-blind, Placebo-controlled, Parallel-group Trial to Assess Clinical Efficacy of NNC0142-0002 in Subjects With Active Rheumatoid Arthritis |
Study Start Date : | August 2010 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 4.0 mg/kg
Subjects received a single dose of 4 mg/kg NNC0142-0002
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Drug: NNC0142-0002
A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin). |
Placebo Comparator: Placebo
Subjects received a single dose of placebo
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Drug: placebo
A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin). |
- Change in DAS28-CRP After 12 Weeks of Treatment [ Time Frame: Week 0, Week 12 ]DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 12 Weeks of treatment.
- Change in DAS28-CRP After 6 Weeks of Treatment. [ Time Frame: Week 0, Week 6 ]DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 6 Weeks of treatment.
- Change in DAS28-CRP After 24 Weeks of Treatment. [ Time Frame: Week 0, Week 24 ]DAS28-CRP=0.56×sqrt(tender joints [count:1-28])+0.28×sqrt(swollen joints [count:1-28])+0.36×Ln(CRP level+1)+0.014×(patient's disease assessment on 0-100 mm scale [100=most severe])+0.96. Range: 0.96 to no upper limit. Higher score=more severe disease. Mean change in DAS-CRP score after 24 Weeks of treatment.

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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 American College of Rheumatology 1987 (ACR1987) criteria, obtained at least three months prior to dosing with the trial product
- Subjects with active RA having a Disease Activity Score (DAS28-CRP) of 4.5 or more, at least five tender and five swollen joints (can be the same), including one swollen wrist or at least two swollen ipsilateral metacarpophalangeal (MCP) joints (second to fifth)
- Concomitant treatment with methotrexate (MTX) (7.5-25 mg/week) for at least 12 weeks, with stable dose for at least 4 weeks prior to dosing
- Ability to be examined by Magnetic Resonance Imaging (MRI)
- Having failed no biologic therapies for RA and no more than two non-biologic disease modifying antirheumatic drugs
Exclusion Criteria:
- Chronic inflammatory autoimmune disease other than RA (rheumatoid arthritis)
- Any ongoing chronic or active infectious disease or microbial infection requiring systemic oral or intravenous treatment against infection within 1 month prior to trial start
- Body mass index (BMI) below or equal to 18 or above or equal to 40 kg/m^2

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): NCT01181050
Germany | |
Berlin, Germany, 13353 | |
Russian Federation | |
Moscow, Russian Federation, 109240 | |
Ukraine | |
Kiev, Ukraine, 03680 |
Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk A/S |
Responsible Party: | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier: | NCT01181050 |
Other Study ID Numbers: |
NN8555-3796 U1111-1114-9194 ( Other Identifier: WHO ) 2010-019261-28 ( EudraCT Number ) |
First Posted: | August 13, 2010 Key Record Dates |
Results First Posted: | April 28, 2014 |
Last Update Posted: | October 3, 2016 |
Last Verified: | August 2016 |
Arthritis Arthritis, Rheumatoid Inflammation Joint Diseases Musculoskeletal Diseases |
Pathologic Processes Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |