Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab

NCT01752855 | Completed Phase 2 Results

• 2 other identifiers: M13-6922012-003881-42
• Study Type: interventional
• Target: 88
• Locations: 7 countries
• Sites: 20

Brief Summary

A Phase 2b, open-label extension (OLE) study in rheumatoid arthritis (RA) patients designed to collect long-term safety, tolerability, efficacy, and immunogenicity data of the proposed new adalimumab formulation.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Mean Change From Baseline in Disease Activity Score 28 (DAS28) at Weeks 36 and 48

  The Disease Activity Score (DAS28) is a validated index of rheumatoid arthritis disease activity. Twenty-eight tender joint counts, 28 swollen joint counts, C-reactive protein, and general health are included in the DAS28 score. Scores on the DAS28 range from 0 to 10. A DAS28 score \>5.1 indicates high disease activity, a DAS28 score \<3.2 indicates low disease activity, and a DAS28 score \<2.6 indicates clinical remission.

  Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

• Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 36 and 48

  American College of Rheumatology 20% (ACR20) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 20% improvement in tender joint count; * ≥ 20% improvement in swollen joint count; and * ≥ 20% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment * CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))

  Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

• Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 36 and 48

  American College of Rheumatology 50% (ACR50) response. A participant is a responder if the following 3 criteria for improvement from baseline are met: * ≥ 50% improvement in tender joint count; * ≥ 50% improvement in swollen joint count; and * ≥ 50% improvement in at least 3 of the 5 following parameters: * Physician global assessment of disease activity * Patient global assessment of disease activity * Patient assessment of pain * Disability Index of the Health Assessment * CRP (Acute phase reactant (Erythrocyte sedimentation rate/C-reactive protein))

  Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

• Mean Change From Baseline in Health Assessment Questionnaire (HAQ-DI) at Weeks 36 and 48

  The Health Assessment Questionnaire - Disability Index (HAQ-DI) is a patient-reported questionnaire specific for rheumatoid arthritis. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and daily activities. Participants assessed their ability to do each task over the past week using the following response categories: without any difficulty (0); with some difficulty (1); with much difficulty (2); and unable to do (3). Scores on each task were summed and averaged to provide an overall score ranging from 0 to 3, where zero represents no disability and three very severe, high-dependency disability. The minimal clinically important difference (MCID) defined for the HAQ-DI is 0.22. HAQ remission indicating normal physical function is defined by HAQ-DI \< 0.5.

  Baseline (Study NCT01712178 Week 0 Visit), Weeks 36 and 48

Secondary Outcomes (1)

• Percentage of Participants Positive for Anti-adalimumab Antibody

  Week 24 through Week 48

Study Arms (1)

New formulation of adalimumab 40 mg every other week

EXPERIMENTAL

New formulation adalimumab 40 mg every other week

Biological: New formulation adalimumab

Interventions

New formulation adalimumab BIOLOGICAL

New formulation adalimumab 40 mg every other week

Also known as: Humira

New formulation of adalimumab 40 mg every other week

Eligibility Criteria

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

You may qualify if:

• Subject has completed the preceding Study M13-390 for rheumatoid arthritis and has not developed any discontinuation criteria from that study.
• If female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy) or is of childbearing potential and is practicing an approved method of birth control throughout the study and for 150 days after last dose of study drug. Examples of approved methods of birth control include the following (see local informed consent for more detail):
• Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD);
• Hormonal contraceptives for 90 days prior to study drug administration;
• A vasectomized partner.
• Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer SC injections.
• Subject is judged to be in good general health as determined by the Principal Investigator based upon the results of medical history, physical examination, laboratory profile performed at Baseline.
• Subjects must be able and willing to provide written informed consent and to comply with the requirements of this study protocol.

You may not qualify if:

• Ongoing infections at Week 0 that have NOT been successfully treated. Subjects with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated.
• Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
• Subject plans to use any live vaccine during the study.
• Positive pregnancy test at Baseline (Week 0).
• Subject is considered by the investigator, for any reason, to be an unsuitable candidate for the study.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (20)

Site Reference ID/Investigator# 92113

Mesa, Arizona, 85202, United States

Location

Site Reference ID/Investigator# 92118

Hemet, California, 92543, United States

Location

Site Reference ID/Investigator# 92117

Wichita, Kansas, 67203, United States

Location

Site Reference ID/Investigator# 92115

Clifton, New Jersey, 07012, United States

Location

Site Reference ID/Investigator# 92116

Philadelphia, Pennsylvania, 19152, United States

Location

Site Reference ID/Investigator# 92114

Charleston, South Carolina, 29406, United States

Location

Site Reference ID/Investigator# 92053

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator# 92054

Liège, 4000, Belgium

Location

Site Reference ID/Investigator# 91954

Brno, 638 00, Czechia

Location

Site Reference ID/Investigator# 91955

Prague, 128 50, Czechia

Location

Site Reference ID/Investigator# 91953

Uherské Hradiště, 686 01, Czechia

Location

Site Reference ID/Investigator# 91956

Zlín, 760 01, Czechia

Location

Site Reference ID/Investigator# 92073

Ratingen, 40882, Germany

Location

Site Reference ID/Investigator# 92074

Vega Baja, 00693, Puerto Rico

Location

Site Reference ID/Investigator# 92093

Bucharest, 020475, Romania

Location

Site Reference ID/Investigator# 92095

Cluj-Napoca, 400006, Romania

Location

Site Reference ID/Investigator# 92094

Ploieşti, 100337, Romania

Location

Site Reference ID/Investigator# 92096

Banská Bystrica, 97405, Slovakia

Location

Site Reference ID/Investigator# 92097

Senica, 905 01, Slovakia

Location

Site Reference ID/Investigator# 92098

Žilina, 010 01, Slovakia

Location

Related Links

• This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor, Abbott)

800-633-9110

Study Officials

• Andy Payne, PhD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2012
• First Posted: December 19, 2012
• Study Start: December 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 29, 2014
• Results First Posted: October 29, 2014

Record last verified: 2014-10

Locations

CZ (4); PR (1); US (6); RO (3); SL (3); BE (2); DE (1)