Inflammation, Rheumatoid Arthritis
Conditions
Brief summary
This trial is conducted in Europe. The aim of this trial is to evaluate the clinical efficacy of a single dose of NNC0142-0002 administered to subjects with active rheumatoid arthritis (RA).
Interventions
DRUGNNC0142-0002
A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).
DRUGplacebo
A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).
Sponsors
Janssen Research & Development, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in DAS28-CRP After 12 Weeks of Treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in DAS28-CRP After 6 Weeks of Treatment. | 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. | 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. |
Countries
Germany, Russia, Ukraine
Participant flow
Recruitment details
The trial was conducted at 8 trial sites in 3 different countries (Germany, the Russian Federation and Ukraine) as follows: Germany: 1 site, the Russian Federation: 6 sites and Ukraine: 1 site. All sites enrolled, randomised and dosed at least 1 subject.
Participants by arm
| Arm | Count |
|---|---|
| 4.0 mg/kg Subjects received a single dose of 4 mg/kg NNC0142-0002 | 41 |
| Placebo Subjects received a single dose of placebo | 22 |
| Total | 63 |
Baseline characteristics
| Characteristic | 4.0 mg/kg | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 52.6 years STANDARD_DEVIATION 10.8 | 52.0 years STANDARD_DEVIATION 10.8 | 52.4 years STANDARD_DEVIATION 10.7 |
| DAS28-CRP (Disease Activity Score based on count of 28 joints and the C-reactive protein) | 5.4 scores STANDARD_DEVIATION 0.9 | 5.4 scores STANDARD_DEVIATION 1 | 5.4 scores STANDARD_DEVIATION 0.9 |
| Sex: Female, Male Female | 38 Participants | 19 Participants | 57 Participants |
| Sex: Female, Male Male | 3 Participants | 3 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / 41 | 5 / 22 |
| serious Total, serious adverse events | 3 / 41 | 1 / 22 |
Outcome results
Primary
Change in DAS28-CRP After 12 Weeks of Treatment
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.
Time frame: Week 0, Week 12
Population: Change in DAS28-CRP was calculated by using last observation carried forward method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4.0 mg/kg | Change in DAS28-CRP After 12 Weeks of Treatment | -1.0 scores | Standard Deviation 1 |
| Placebo | Change in DAS28-CRP After 12 Weeks of Treatment | -1.0 scores | Standard Deviation 1 |
p-value: 0.933495% CI: [-0.54, 0.5]Mixed effect model repeated measures
Secondary
Change in DAS28-CRP After 24 Weeks of Treatment.
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.
Time frame: Week 0, Week 24
Population: Change in DAS28-CRP was calculated by using last observation carried forward method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4.0 mg/kg | Change in DAS28-CRP After 24 Weeks of Treatment. | -1.3 scores | Standard Deviation 1.1 |
| Placebo | Change in DAS28-CRP After 24 Weeks of Treatment. | -1.3 scores | Standard Deviation 1.1 |
p-value: 0.886795% CI: [-0.65, 0.56]Mixed effect model repeated measures
Secondary
Change in DAS28-CRP After 6 Weeks of Treatment.
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.
Time frame: Week 0, Week 6
Population: Change in DAS28-CRP was calculated by using last observation carried forward method.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4.0 mg/kg | Change in DAS28-CRP After 6 Weeks of Treatment. | -0.9 scores | Standard Deviation 1.1 |
| Placebo | Change in DAS28-CRP After 6 Weeks of Treatment. | -1.0 scores | Standard Deviation 0.8 |
p-value: 0.829395% CI: [-0.46, 0.58]Mixed effect model repeated measures