INCB028050 Compared to Background Therapy in Patients With Active Rheumatoid Arthritis (RA) With Inadequate Response to Disease Modifying Anti-Rheumatic Drugs

NCT00902486 | Completed Phase 2 Results

• 1 other identifier: INCB 28050-201
• Study Type: interventional
• Target: 127
• Locations: 2 countries
• Sites: 49

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritis

Outcome Measures

Primary Outcomes (2)

• The Percentage of Participants Achieving American College of Rheumatology (ACR) 20 Improvement

  The ACR 20 is defined as ≥ 20% improvement in tender joint count plus ≥ 20% improvement in swollen joint count plus ≥ 20% improvement in 3 of the following 5 criteria: participants' assessment of pain, participants' global assessment of disease activity (PGA), Physician's global assessment of disease activity (PHGA), participants' self-assessed disability Health Assessment Questionnaire (HAQ), and Erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP), whichever shows the greatest change.

  Week 12

• Participants With at Least 1 Adverse Event From Baseline Through Week 12

  From Baseline through week 12

Secondary Outcomes (28)

• Participants With at Least 1 Adverse Event From Week 12 to Week 24

  Week 12 to Week 24

• The Percentage of Participants Who Were Assigned to Active Treatment at Baseline Achieving ACR 20 Improvement at Week 24

  From Baseline to Week 24

• The Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Improvement at Week 12 and Week 24

  Week 12 and Week 24

• The Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Improvement at Week 12 and Week 24

  Week 12 and Week 24

• The Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Improvement at Week 12 and Week 24

  Week 12 and Week 24

Study Arms (4)

INCB028050 4 mg QD

EXPERIMENTAL

INCB028050 4mg Once daily (QD)

Drug: INCB028050

INCB028050 7 mg QD

EXPERIMENTAL

INCB028050 7mg QD

Drug: INCB028050

INCB028050 10 mg QD

EXPERIMENTAL

INCB028050 10mg QD

Drug: INCB028050

Placebo

PLACEBO COMPARATOR

Placebo group may 'cross-over' following 3 months of treatment to receive either active arm #2 (7mg QD) or active arm #3 (10mg QD) of INCB028050 capsules.

Drug: Placebo

Interventions

INCB028050 DRUG

4 mg capsules QD

Also known as: Baricitinib

INCB028050 4 mg QD

Placebo DRUG

Placebo matching INCB028050 QD

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (49)

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Birmingham, Alabama, United States

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Paradise Valley, Arizona, United States

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Peoria, Arizona, United States

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Phoenix, Arizona, United States

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Palm Desert, California, United States

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Santa Maria, California, United States

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Santa Monica, California, United States

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Westlake Village, California, United States

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Whittier, California, United States

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Denver, Colorado, United States

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Aventura, Florida, United States

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Daytona Beach, Florida, United States

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Gainesville, Florida, United States

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Lake Mary, Florida, United States

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Naples, Florida, United States

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Palm Harbor, Florida, United States

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Sarasota, Florida, United States

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Springfield, Illinois, United States

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South Bend, Indiana, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Frederick, Maryland, United States

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Wheaton, Maryland, United States

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St Louis, Missouri, United States

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Lincoln, Nebraska, United States

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Reno, Nevada, United States

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Freehold, New Jersey, United States

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Lake Success, New York, United States

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Syracuse, New York, United States

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Charlotte, North Carolina, United States

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Hickory, North Carolina, United States

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Middleburg Heights, Ohio, United States

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Toledo, Ohio, United States

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Tulsa, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Sellersville, Pennsylvania, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Arlington, Virginia, United States

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Spokane, Washington, United States

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Brno, Czechia

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Chomutov, Czechia

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Česká Lípa, Czechia

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Hlučín, Czechia

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Hustopeče, Czechia

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Kroměříž, Czechia

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Prague, Czechia

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Zlín, Czechia

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Related Publications (3)

• Taylor PC, Takeuchi T, Burmester GR, Durez P, Smolen JS, Deberdt W, Issa M, Terres JR, Bello N, Winthrop KL. Safety of baricitinib for the treatment of rheumatoid arthritis over a median of 4.6 and up to 9.3 years of treatment: final results from long-term extension study and integrated database. Ann Rheum Dis. 2022 Mar;81(3):335-343. doi: 10.1136/annrheumdis-2021-221276. Epub 2021 Oct 27.

  PMID: 34706874 DERIVED

• Combe B, Balsa A, Sarzi-Puttini P, Tony HP, de la Torre I, Rogai V, Durand F, Witt S, Zhong J, Dougados M. Efficacy and safety data based on historical or pre-existing conditions at baseline for patients with active rheumatoid arthritis who were treated with baricitinib. Ann Rheum Dis. 2019 Aug;78(8):1135-1138. doi: 10.1136/annrheumdis-2018-214261. Epub 2019 Mar 6. No abstract available.

  PMID: 30842122 DERIVED

• Taylor PC, Kremer JM, Emery P, Zuckerman SH, Ruotolo G, Zhong J, Chen L, Witt S, Saifan C, Kurzawa M, Otvos JD, Connelly MA, Macias WL, Schlichting DE, Rooney TP, de Bono S, McInnes IB. Lipid profile and effect of statin treatment in pooled phase II and phase III baricitinib studies. Ann Rheum Dis. 2018 Jul;77(7):988-995. doi: 10.1136/annrheumdis-2017-212461. Epub 2018 Feb 20.

  PMID: 29463520 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

baricitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

855 463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2009
• First Posted: May 15, 2009
• Study Start: May 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: July 1, 2010
• Last Updated: September 4, 2018
• Results First Posted: September 4, 2018

Record last verified: 2018-08

Locations

CZ (8); US (41)