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Trial record 2 of 2 for:    FKB327

A Study to Compare FKB327 Long-term Safety, Efficacy and Immunogenicity With Humira® in Rheumatoid Arthritis Patients (ARABESC-OLE)

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ClinicalTrials.gov Identifier: NCT02405780
Recruitment Status : Completed
First Posted : April 1, 2015
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Fujifilm Kyowa Kirin Biologics Co., Ltd.

Brief Summary:
The purpose of the study is to compare the safety, effectiveness and immunogenicity of FKB327 in comparison to Humira® in rheumatoid arthritis patients who have completed study FKB327-002 and have inadequate disease control on methotrexate.

Condition or disease Intervention/treatment Phase
Arthritis, Rheumatoid Drug: FKB327 Drug: Humira® Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Extension Study to Compare the Long-term Efficacy, Safety, Immunogenicity and Pharmacokinetics of FKB327 and Humira® in Patients With Rheumatoid Arthritis on Concomitant Methotrexate
Actual Study Start Date : June 10, 2015
Actual Primary Completion Date : January 18, 2018
Actual Study Completion Date : January 18, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Adalimumab

Arm Intervention/treatment
Experimental: FKB327
Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.
Drug: FKB327
Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.

Active Comparator: Humira®
Patients will receive the drug 40 mg every other week by subcutaneous injection. The treatment period may continue for 76 weeks.
Drug: Humira®
Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.




Primary Outcome Measures :
  1. Number of patients with Adverse Events as a measure of safety [ Time Frame: Up to Week 80 ]
  2. Number of patients with Serious Adverse Events as a measure of safety [ Time Frame: Up to Week 80 ]
  3. Number of patients with changes in Vital Signs as a measure of safety [ Time Frame: Up to Week 80 ]
  4. Number of patients with changes in Clinical Laboratory Tests as a measure of safety [ Time Frame: Up to Week 80 ]

Secondary Outcome Measures :
  1. Changes in Disease Activity Score 28 based on C reactive protein (DAS28 CRP) score compared to baseline as a measure of efficacy [ Time Frame: From Week 0 of FKB327-002 to Week 80 ]
  2. American College of Rheumatology 20 (ACR20) response rates from baseline as a measure of efficacy [ Time Frame: From Week 0 of FKB327-002 to Week 80 ]
  3. American College of Rheumatology 50 (ACR50) response rates from baseline as a measure of efficacy [ Time Frame: From Week 0 of FKB327-002 to Week 80 ]
  4. American College of Rheumatology 70 (ACR70) response rates from baseline as a measure of efficacy [ Time Frame: From Week 0 of FKB327-002 to Week 80 ]

Other Outcome Measures:
  1. Proportion of patients developing Anti-drug antibodies (ADAs) [ Time Frame: Week 80 ]
  2. Trough adalimumab concentration [ Time Frame: Week 80 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient has completed the Week 24 visit procedures of Study FKB327-002 and are continuing with methotrexate
  2. In the investigator's opinion, the patient showed a clinical response to treatment during Study FKB327-002

Exclusion Criteria:

  1. Patient has evidence of a serious adverse event (SAE) ongoing from Study FKB327-002
  2. Patient has presence of active and/or untreated latent tuberculosis (TB)

Other Inclusion/Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02405780


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Sponsors and Collaborators
Fujifilm Kyowa Kirin Biologics Co., Ltd.
Investigators
Principal Investigator: Josephine Glover, MD Coephycient Pharmaceutical Consultancy

Responsible Party: Fujifilm Kyowa Kirin Biologics Co., Ltd.
ClinicalTrials.gov Identifier: NCT02405780     History of Changes
Other Study ID Numbers: FKB327-003
First Posted: April 1, 2015    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018

Keywords provided by Fujifilm Kyowa Kirin Biologics Co., Ltd.:
Rheumatoid
Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents