Phase 2
Completed N=127
INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs
Source: ClinicalTrials.gov NCT00902486 ↗Enrolled (actual)
127
Serious AEs
0.9%
Results posted
Sep 2018
Primary outcomePrimary: The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement — 10; 16; 19; 16 Participants — p=0.0619
Summary
This was a randomized, double blind, placebo controlled, dose ranging, parallel group study. Participants who had active rheumatoid arthritis (RA) who had inadequate response to any disease modifying anti-rheumatic drug (DMARD) therapy including biologics were enrolled. Screening evaluations were performed within approximately 28 days of randomization. The duration of the study was 6 months with the primary endpoint assessed at 3 months. Eligible participants were randomly assigned to one of three doses (4, 7 or 10 mg QD) of INCB028050 (Baricitinib) or placebo.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement |
10; 16; 19; 16 | 0.0619 |
| PRIMARY Participants With at Least 1 Adverse Event From Baseline Through Week 12 |
19; 15; 20; 23 | — |
| SECONDARY Participants With at Least 1 Adverse Event From Week 12 to Week 24 |
6; 5; 12; 16; 16 | — |
| SECONDARY The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24 |
18; 20; 18 | — |
| SECONDARY The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24 |
13.0; 35.0; 31.0; 30.0; NA; 33.0 | — |
| SECONDARY The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24 |
3.0; 16.0; 9.0; 10.0; NA; 26.0 | — |
| SECONDARY The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24 |
0.0; 3.0; 0.0; 3.0; NA; 11.0 | — |
| SECONDARY Change in Disease Activity Score 28 (DAS28) CRP Score From Baseline at Week 12 and Week 24 |
5.71; 5.64; 5.76; 5.64; -1.01; -1.87 | — |
| SECONDARY Change in Disease Activity Score 28 (DAS28) ESR Score From Baseline at Week 12 and Week 24 |
6.56; 6.41; 6.35; 6.37; -1.25; -1.87 | — |
| SECONDARY Percentage of Participants Achieving Low Disease Activity by DAS28 (ESR)≤3.2 |
19.0; 23.0; 31.0; 13.0; NA; 48.0 | — |
| SECONDARY Percentage of Participants Achieving Remission by DAS28 (ESR) ≤2.6 |
6.7; 18.8; 16.0; 19.0; 7.0; 21.4 | — |
| SECONDARY Percentage of Participants Achieving Remission by DAS28 (CRP) ≤2.6 |
23.0; 25.0; 17.0; 30.0; 40.0; 48.0 | — |
| SECONDARY Change in ACR Assessment Tender Joint Count (TJC) From Baseline to Week 12 and Week 24 |
15.9; 14.4; 14.7; 15.9; -5.3; -7.4 | — |
| SECONDARY Change in ACR Assessment Swollen Joint Count (SJC) From Baseline to Week 12 and Week 24 |
11.0; 12.0; 10.6; 12.9; -3.7; -6.1 | — |
| SECONDARY Change in Participants' Assessment of Pain From Baseline at Week 12 and Week 24 |
62.37; 57.08; 63.25; 57.00; -6.24; -21.98 | — |
| SECONDARY Change in Participants' Global Assessment of Disease Activity From Baseline at Week 12 and Week 24 |
66.19; 59.02; 69.69; 62.25; -8.61; -22.06 | — |
| SECONDARY Change in Physician's Global Assessment of Disease Activity (PGA) From Baseline at Week 12 and Week 24 |
63.45; 61.94; 59.80; 59.32; -20.23; -33.87 | — |
| SECONDARY Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) From Baseline at Week 12 and Week 24 |
1.61; 1.50; 1.67; 1.50; -0.20; -0.38 | — |
| SECONDARY Change in Erythrocyte Sedimentation Rate (ESR) From Baseline at Week 12 and Week 24 |
40.8; 42.8; 37.3; 34.8; -6.1; -7.5 | — |
| SECONDARY Change in C-reactive Protein (CRP) From Baseline at Week 12 and Week 24 |
10.89; 15.63; 15.64; 7.52; 0.18; -9.76 | — |
| SECONDARY Change in Duration of Morning Stiffness From Baseline at Week 12 and Week 24 |
78.5; 179.8; 125.5; 79.2; 2.6; -51.1 | — |
| SECONDARY Percentage of Participants Achieving Good European League Against Rheumatism (EULAR) Response (DAS28 ESR) at Week 12 |
19.0; 23.0; 31.0; 13.0 | — |
| SECONDARY Percentage of Participants Achieving Good EULAR Response (DAS28ESR) at Week 24 |
21.0; 15.0; 33.0; 43.0; 39.0 | — |
| SECONDARY Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 12 |
26.0; 39.0; 34.0; 33.0 | — |
| SECONDARY Percentage of Participants Achieving Good EULAR Response (DAS28CRP) at Week 24 |
48.0; 53.0; 65.0 | — |
| SECONDARY Change in SF-36 Mental Component Summary From Baseline at Week 12 and Week 24 |
71.08; 69.03; 78.41; 78.62; 2.92; 7.87 | — |
| SECONDARY Change in SF-36 Physical Component Summary From Baseline at Week 12 and Week 24 |
29.14; 34.67; 26.71; 28.82; 3.72; 9.57 | — |
| SECONDARY Percent of Participants Achieving a Minimum Clinically Important Difference (MCID) in the Health Assessment Questionnaire Disability Index (HAQ-DI) at Week 12 and Week 24 |
45.0; 61.0; 63.0; 43.0; NA; 67.0 | — |
| SECONDARY Percent of Participants Achieving a MCID in the Pain Score (Participant's Assessment of Pain) at Week 12 and Week 24 |
35.0; 58.0; 69.0; 67.0; NA; 59.0 | — |
| SECONDARY Percent of Participants Achieving a MCID in the SF-36 Physical Components and Mental Components at Week 12 and Week 24 |
52.0; 68.0; 69.0; 57.0; NA; 67.0 | — |
Eligibility Criteria
Inclusion Criteria
- Must have rheumatoid arthritis which has been inadequately controlled with at least one DMARD
- For subjects receiving antimalarials, they must be treated with antimalarials for at least 6 months and receiving a stable daily dose
- For subjects receiving sulfasalazine, they must be treated with Sulfasalazine (SSZ) for at least 6 months and receiving a stable daily dose of no more than 3 grams per day
- For subjects on methotrexate, they must be treated with methotrexate for at least 6 months, and receiving a stable weekly dose of methotrexate between 7.5 and 25 mg
- For subjects on leflunomide, they must be treated with leflunomide for at least 6 months, and receiving a stable dose of leflunomide between 10 to 20 mg
- For subjects receiving corticosteroids, they must be on a dose not to exceed 10 mg of prednisone daily
- Active rheumatoid arthritis at the time of screening defined by the following: 6 or more joints tender or painful on motion and 4 or more swollen joints and at least one of the following two: Erythrocyte sedimentation rate (ESR) greater than or equal to 28 mm/hr or C-reactive protein (CRP) greater than or equal to 7 mg/liter
- Have evidence of lack of risk for tuberculosis
Exclusion Criteria
- Current or recent viral, bacterial, fungal, parasitic or mycobacterial infection requiring systemic therapy
- History of infected joint prosthesis
- Subjects who have a current or recent history of severe, progressive, uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, neurological or cerebral disease
- Subjects who have received treatment with the following drugs or drug classes within the specified timeframe: prior treatment with rituximab within 12 months, prior treatment with an oral Janus kinase (JAK) inhibitor, DMARDs or other anti-rheumatic therapies not specified and allowed according to protocol, treatment with any investigational medication within 12 weeks or 5 half-lives (whichever is longer), and treatment with a biologic agent within 12 weeks prior to the first dose of study medication
- Subjects with a past history of neutropenia, thrombocytopenia or anemia requiring transfusion other than at the time of trauma or surgery, and subjects that meet protocol specified laboratory measures
Data sourced from ClinicalTrials.gov (NCT00902486). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.