A Study of CNTO 136 (Sirukumab) Administered Subcutaneously in Japanese Patients With Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine

NCT01689532 | Completed Phase 3 Results DMC

• 2 other identifiers: CR100876CNTO136ARA3001
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 17

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of sirukumab as a single therapy in Japanese patients with moderately to severely active rheumatoid arthritis (RA) who have not responded to treatment with methotrexate (MTX) or sulfasalazine (SSZ).

Conditions

Arthritis, Rheumatoid

Keywords

Active Rheumatoid Arthritis Unresponsive to Methotrexate or Sulfasalazine; Sirukumab; Human Anti-IL-6 Monoclonal Antibody

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment Emergent Adverse Events (TEAE)

  A TEAE was defined as an event that occurred in the treatment period during which it emerged (that is \[i.e.\] started or worsened in severity, relation, or other attribute), and even if the event continued to be present.

  Baseline upto Week 68

Secondary Outcomes (28)

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

  At Weeks 16 and 24

• Percentage of Participants Achieving American College of Rheumatology (ACR) 50 Response

  At Weeks 16 and 24

• Percentage of Participants Achieving American College of Rheumatology (ACR) 70 Response

  At Weeks 16 and 24

• Percentage of Participants Achieving American College of Rheumatology (ACR) 90 Response

  At Weeks 16 and 24

• Percent Change From Baseline in Number of Swollen Joints at Weeks 16 and 24

  Baseline, Weeks 16 and 24

Study Arms (2)

Sirukumab 100 mg

EXPERIMENTAL

Drug: Sirukumab 100 mg

Sirukumab 50 mg and Placebo

EXPERIMENTAL

Drug: Sirukumab 50 mg; Drug: Placebo

Interventions

Sirukumab 100 mg DRUG

Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52.

Sirukumab 100 mg

Sirukumab 50 mg DRUG

Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52.

Sirukumab 50 mg and Placebo

Placebo DRUG

Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.

Sirukumab 50 mg and Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be a Japanese man or woman with a diagnosis of rheumatoid arthritis (RA), according to the revised 1987 criteria of the American Rheumatism Association, for at least 3 months before screening
• Has moderately to severely active RA with at least 6 of 68 tender joints and 6 of 66 swollen joints, at screening and at baseline
• Has been unresponsive to adequate treatment with methotrexate (MTX), sulfasalazine (SSZ), or combination of MTX or SSZ with other disease-modifying antirheumatic drugs (DMARDs) at screening due to lack of benefit after at least 12 weeks of marketed dose of MTX or SSZ, as assessed by the treating physician. Documented lack of benefit may include inadequate improvement in joint counts, physical function, or overall disease activity
• If using oral corticosteroids, must be on a stable dose equivalent to \<=10 mg/day of prednisolone for at least 2 weeks prior to first dosing with study agent. If currently not using corticosteroids, the patient must not have received oral corticosteroids (by mouth) for at least 2 weeks prior to first dosing with study agent
• If using nonsteroidal anti-inflammatory drugs (NSAIDs) or other analgesics (pain relievers) for RA, must be on a stable dose for at least 2 weeks prior to first dosing with study agent

You may not qualify if:

• Has a history of intolerance to at least 2 or inadequate response to at least one anti-tumor necrosis factor-alpha (anti-TNF-alpha) agent after 3 months of therapy; has received anti-TNF-alpha (eg, infliximab, golimumab, adalimumab, or etanercept) within 3 months of first study agent dosing
• Has a history of intolerance to tocilizumab that precluded further treatment with it, or inadequate response to 3 months of tocilizumab (anti-IL-6 receptor) therapy; has used B-cell-depleting therapy (eg, rituximab) within 7 months of first study agent dosing or has evidence during screening of abnormally low B-cell level caused by previous B-cell depletion therapy; has used any other biologic therapy for the treatment of RA within 3 months of first study agent dosing; has a history of sirukumab use
• Has received intra-articular (IA), intramuscular (IM), or intravenous (IV) corticosteroids for RA, including adrenocorticotrophic hormone during the 4 weeks prior to first study agent dosing
• Has received leflunomide within 24 months before first study agent dosing and has not undergone a drug elimination procedure, unless the M1 metabolite is measured and is undetectable. Drug elimination procedure must be completed prior to obtaining informed consent
• Has a history of cyclophosphamide or cytotoxic agent use; has received cyclosporine A, azathioprine, tacrolimus, mycophenolate mofetil, oral or parenteral gold, or D-penicillamine within 4 weeks of first study agent dosing; has received an investigational drug (including investigational vaccines) or used an investigational medical device within 3 months or 5 half-lives, whichever is longer, before first study agent dosing

Sponsors & Collaborators

• Janssen Pharmaceutical K.K.: lead
• GlaxoSmithKline: collaborator

Study Sites (17)

Unknown Facility

Asahikawa, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Hiroshima, Japan

Location

Unknown Facility

Hitachi-Naka, Japan

Location

Unknown Facility

Kagoshima, Japan

Location

Unknown Facility

Kirishima, Japan

Location

Unknown Facility

Kitakyushu, Japan

Location

Unknown Facility

Kobe, Japan

Location

Unknown Facility

Kumamoto, Japan

Location

Unknown Facility

Matsumoto, Japan

Location

Unknown Facility

Miyagi, Japan

Location

Unknown Facility

Ōita, Japan

Location

Unknown Facility

Sapporo, Japan

Location

Unknown Facility

Sendai, Japan

Location

Unknown Facility

Shizuoka, Japan

Location

Unknown Facility

Tokyo, Japan

Location

Unknown Facility

Yokohama, Japan

Location

Related Publications (1)

• Takeuchi T, Yamanaka H, Harigai M, Tamamura R, Kato Y, Ukyo Y, Nakano T, Hsu B, Tanaka Y. Sirukumab in rheumatoid arthritis refractory to sulfasalazine or methotrexate: a randomized phase 3 safety and efficacy study in Japanese patients. Arthritis Res Ther. 2018 Mar 7;20(1):42. doi: 10.1186/s13075-018-1536-9.

  PMID: 29514712 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

sirukumab

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: Senior Manager
• Organization: Janssen Pharmaceutical K.K.

ClinicalTrialDisclosure@its.jnj.com

Study Officials

• Janssen Pharmaceutical K.K., Japan Clinical Trial

  Janssen Pharmaceutical K.K.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2012
• First Posted: September 21, 2012
• Study Start: November 1, 2012
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 27, 2016
• Results First Posted: October 27, 2016

Record last verified: 2016-09

Locations

JP (17)