Back to results

Efficacy of Humira in Behcet Patients With Arthritis

Primary Purpose

Arthritis; Behcet

Status

Completed

Phase

Phase 3

Locations

Israel

Study Type

Interventional

Intervention

Adalimumab (Humira)

About this trial

This is an interventional treatment trial for Arthritis; Behcet

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Able and willing to give written informed consent and comply with the requirements of the study protocol.
Patients with Behcet disease ,who fulfilled the International Study group criteria for Behcet Disease.
Experienced an inadequate response to previous or current treatment with one or more DMARDs because of inadequate efficacy or side effects.
DMARDS and/or corticosteroids (< or equivalent to 10mg/d prednisone) permitted if stable for at least 4 weeks prior to screening. NSAIDs permitted if stable for at least 2 weeks prior to screening.
Active peripheral arthritis at screening (tenderness and swelling of at least 3 small joints or one large joint) OR axial involvement (active enthesitis or spondylitis)
Age 18-80 years.
If female and of childbearing potential, a negative urine pregnancy test within 2 weeks prior to therapy, and using reliable means of contraception.

Exclusion Criteria:

Rheumatic autoimmune disease other than Behcet (Rheumatoid arthritis, SLE, scleroderma, etc).
Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders.
Known active bacterial, viral, fungal, mycobacterial or other infection, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening.
History of lymphoproliferative or hematologic malignancy. History of any other type of cancer in the past 5 years.

Sites / Locations

Rheumatology Unit, Rambam Health Care Campus

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab, Behcet with arthritis

Arm Description

Outcomes

Primary Outcome Measures

Reduction in DAS28

The proportion of patients with improvement in arthritis (DAS 28) at week 24 -changes from screening in DAS 28 , HAQ, , CRP. ANOVA analysis and descriptive statistics. An interim evaluation of the above parameters will be performed at week 16 (visit 4) and yearly afterwards for 3 more years in those patients who will continue drug study during the extension period

Secondary Outcome Measures

Full Information

NCT ID

NCT01497717

First Posted

December 20, 2011

Last Updated

October 25, 2016

Sponsor

Rambam Health Care Campus

Collaborators

Abbott

1. Study Identification

Unique Protocol Identification Number

NCT01497717

Brief Title

Efficacy of Humira in Behcet Patients With Arthritis

Official Title

Efficacy of Humira in Behcet Patients With Arthritis

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

July 2013 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rambam Health Care Campus

Collaborators

Abbott

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Hypothesis - Behcet's disease is a multisystemic chronic relapsing inflammatory disease, classified among the vasculitides. The clinical manifestations include mucocutaneous lesions, articular, ocular, vascular, gastrointestinal and/or central nervous system involvement. The aetiology of Behcet's disease is unknown, however. Experimental evidence suggests that TNF-α may play an important role in the pathogenesis of the disease. To date, case reports and small open-short term studies report the efficacy of anti-TNFα therapy (Infliximab and Etanercept), especially regarding ocular and mucocutaneous involvement in Behcet. There are no double blind long term studies on larger number of patients regarding the efficacy of anti-TNFα, especially Humira in healing arthritis +/- other manifestations of the disease.

Detailed Description

Study Design (including visit schedule, dosing and procedures/methods): Screen visit, 1st visit -treatment initiation, follow-up visits - after 1 month and afterwards every 8 weeks for 24 weeks. Screen visit: informed consent, medical history,inclusion and exclusion criteria, pregnancy test, vital signs, physical examination, joint evaluation (no. of tender joints, no. of swollen joints), patient/investigator global disease activity, pain VAS, HAQ, Behcet Disease Current Activity Forms (BDACF), ECG, PPD and chest X-ray screening for tuberculosis, routine labs (performed at local HMO as a routine follow-up of the patient treatment with DMARD's): CBC, blood chemistry, ESR, CRP, urinalysis, HbsAg and AntiHCV, immunology labs (rheumatoid factor, anti-CCP, anti nuclear antibody - ANA). An induration of greater than 5 mm will be considered a positive PPD reaction. Follow up visits .: Vital signs, joint evaluation, patient/investigator global disease activity, pain VAS, HAQ, BDACF, routine labs (performed at local HMO as a routine follow-up of the patient treatment with DMARD's): CBC, blood chemistry, ESR, CRP, urinalysis, research blood samples for storage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthritis; Behcet

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab, Behcet with arthritis

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Adalimumab (Humira)

Other Intervention Name(s)

Anti TNF monoclonal antibodies

Intervention Description

Open label pilot trial. The study includes 3 phases : Open label treatment period of 24 weeks. Extension follow -up (3 years): Patients who responded well to study drug and their disease relapsed within the first 12 weeks following study drug interruption will be eligible to receive the study drug for 3 years in order to comply with the Israeli Ministry of Health requirements. Safety follow-up: For patients who withdraw from either the open label treatment period or extension period, for another 24 weeks.

Primary Outcome Measure Information:

Title

Reduction in DAS28

Description

Time Frame

Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able and willing to give written informed consent and comply with the requirements of the study protocol. Patients with Behcet disease ,who fulfilled the International Study group criteria for Behcet Disease. Experienced an inadequate response to previous or current treatment with one or more DMARDs because of inadequate efficacy or side effects. DMARDS and/or corticosteroids (< or equivalent to 10mg/d prednisone) permitted if stable for at least 4 weeks prior to screening. NSAIDs permitted if stable for at least 2 weeks prior to screening. Active peripheral arthritis at screening (tenderness and swelling of at least 3 small joints or one large joint) OR axial involvement (active enthesitis or spondylitis) Age 18-80 years. If female and of childbearing potential, a negative urine pregnancy test within 2 weeks prior to therapy, and using reliable means of contraception. Exclusion Criteria: Rheumatic autoimmune disease other than Behcet (Rheumatoid arthritis, SLE, scleroderma, etc). Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders. Known active bacterial, viral, fungal, mycobacterial or other infection, or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks of screening or oral antibiotics within 2 weeks prior to screening. History of lymphoproliferative or hematologic malignancy. History of any other type of cancer in the past 5 years.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yolanda Braun, MD

Organizational Affiliation

Rheumatology Unit, Rambam Health Care Campus, B. Rappaport Faculty of Medicine, Technion - Institute of Technology, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rheumatology Unit, Rambam Health Care Campus

City

Haifa

ZIP/Postal Code

31096

Country

Israel

12. IPD Sharing Statement

Learn more about this trial

Efficacy of Humira in Behcet Patients With Arthritis

We'll reach out to this number within 24 hrs