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

NCT ID: NCT00902486

Last Updated: 2018-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 127 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

INCB028050 4 mg QD

INCB028050 4mg Once daily (QD)

Group Type: EXPERIMENTAL

INCB028050

Intervention Type: DRUG

4 mg capsules QD

INCB028050 7 mg QD

INCB028050 7mg QD

Group Type: EXPERIMENTAL

INCB028050

Intervention Type: DRUG

7 mg capsules QD

INCB028050 10 mg QD

INCB028050 10mg QD

Group Type: EXPERIMENTAL

INCB028050

Intervention Type: DRUG

10 mg capsule QD

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching INCB028050 QD

Interventions

INCB028050

4 mg capsules QD

Intervention Type: DRUG

INCB028050

7 mg capsules QD

Intervention Type: DRUG

INCB028050

10 mg capsule QD

Intervention Type: DRUG

Placebo

Placebo matching INCB028050 QD

Intervention Type: DRUG

Other Intervention Names

Baricitinib; Baricitinib; Baricitinib

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Birmingham, Alabama, United States

Paradise Valley, Arizona, United States

Peoria, Arizona, United States

Phoenix, Arizona, United States

Palm Desert, California, United States

Santa Maria, California, United States

Santa Monica, California, United States

Westlake Village, California, United States

Whittier, California, United States

Denver, Colorado, United States

Aventura, Florida, United States

Daytona Beach, Florida, United States

Gainesville, Florida, United States

Lake Mary, Florida, United States

Naples, Florida, United States

Palm Harbor, Florida, United States

Sarasota, Florida, United States

Springfield, Illinois, United States

South Bend, Indiana, United States

Wichita, Kansas, United States

Lexington, Kentucky, United States

Frederick, Maryland, United States

Wheaton, Maryland, United States

St Louis, Missouri, United States

Lincoln, Nebraska, United States

Reno, Nevada, United States

Freehold, New Jersey, United States

Lake Success, New York, United States

Syracuse, New York, United States

Charlotte, North Carolina, United States

Hickory, North Carolina, United States

Middleburg Heights, Ohio, United States

Toledo, Ohio, United States

Tulsa, Oklahoma, United States

Duncansville, Pennsylvania, United States

Pittsburgh, Pennsylvania, United States

Sellersville, Pennsylvania, United States

Houston, Texas, United States

San Antonio, Texas, United States

Arlington, Virginia, United States

Spokane, Washington, United States

Brno, , Czechia

Chomutov, , Czechia

Česká Lípa, , Czechia

Hlučín, , Czechia

Hustopeče, , Czechia

Kroměříž, , Czechia

Prague, , Czechia

Zlín, , Czechia

Countries

United States; Czechia

References

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.

Reference Type: DERIVED

PMID: 34706874 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30842122 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29463520 (View on PubMed)

Other Identifiers

INCB 28050-201

Identifier Type: -

Identifier Source: org_study_id