A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety

NCT01712178 | Completed Phase 2 Results

• 2 other identifiers: M13-3902012-000535-36
• Study Type: interventional
• Target: 100
• Locations: 7 countries
• Sites: 21

Brief Summary

A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for pharmacodynamics, pharmacokinetics, and safety.

Conditions

Rheumatoid Arthritis

Keywords

Pharmacodynamic,Pharmacokinetic

Outcome Measures

Primary Outcomes (2)

• Serum Concentrations of Adalimumab at Weeks 12 and 24

  Blood samples for adalimumab analysis were collected by venipuncture and serum concentrations of adalimumab were determined using a validated enzyme-linked immunoadsorbent assay (ELISA) method.

  Measured at Weeks 12 and 24

• Mean Disease Activity Scores (DAS28) at Weeks 12 and 24

  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.

  Measured at Weeks 12 and 24

Secondary Outcomes (7)

• Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24

  Measured at Weeks 12 and 24

• Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24

  Measured at Weeks 12 and 24

• Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24

  Measured at Weeks 12 and 24

• Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24

  Measured at Weeks 12 and 24

• Percentage of Participants Positive for Anti-adalimumab Antibody

  Measured through Week 24

Study Arms (2)

New formulation of adalimumab 40 mg every other week

EXPERIMENTAL

New formulation adalimumab 40 mg every other week

Biological: Adalimumab, new formulation

Current formulation adalimumab 40 mg every other week

ACTIVE COMPARATOR

Current formulation adalimumab 40 mg every other week

Biological: Adalimumab, current formulation

Interventions

Adalimumab, current formulation BIOLOGICAL

Current formulation adalimumab 40 mg every other week

Also known as: Humira

Current formulation adalimumab 40 mg every other week

Adalimumab, new formulation BIOLOGICAL

New formulation adalimumab 40 mg every other week

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:

• Male or female subject, 18 years or older who has a diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987-revised American College of Rheumatology (ACR)-classification criteria or the new American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for RA 2010-classification criteria and has a disease duration for a minimum of 3 months.
• Subjects must be naïve to biologic therapy.
• Subject must meet the following criteria for the joint assessment: • At least 6 swollen joints out of 66 assessed. • At least 6 tender joints out of 68 assessed.
• Prior Disease Modifying Antirheumatic Drug (DMARD) therapy: a) Subjects not on methotrexate at baseline must remain without methotrexate throughout the study. Subjects on prior Methotrexate (MTX) must have discontinued at least 28 days prior to Week 0 (Day 1). b) Subjects on Disease Modifying Antirheumatic Drug (DMARD) therapy other than Methotrexate (MTX) (except prednisone/prednisolone less than or equal to 10 mg) must discontinue it for at least 28 days before the first dose of investigational product at Week 0 (Day 1).
• Female subjects are 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 are practicing at least 1 of the following methods of birth control throughout the study and for at least 150 days after the last dose of study drug: • Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD). • Hormonal contraceptives for 90 days prior to study drug administration. • Vasectomized partner(s).
• Subjects must be able and willing to self-administer subcutaneous (SC) injections or have a qualified person available to administer subcutaneous (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, chest x-ray (CXR), and 12 lead electrocardiogram (ECG) performed during Screening.
• Subject has a negative Tuberculosis (TB) screening assessment (including a (Purified Protein Derivative (PPD) test or QuantiFERON-Tuberculosis (TB) Gold test or equivalent) and negative chest x-ray (Posterior-Anterior (PA) and lateral view) at Screening. If a subject has evidence of a latent Tuberculosis (TB) infection, the subject must initiate and complete a minimum of 2 weeks of anti-Tuberculosis (TB) therapy or have documented completion of a course of anti-Tuberculosis (TB) therapy prior to Baseline.
• Subjects must be willing to provide written consent and to comply with the requirements of this study protocol.

You may not qualify if:

• Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks from Baseline visit. Inhaled corticosteroids for stable medical conditions are allowed. Oral of less than or equal to 10 mg/d prednisone equivalent are allowed.
• Subject has been treated with any investigational drug of a chemical or biological nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to Baseline Visit.
• Subject has a history of acute inflammatory joint disease of different origin other than Rheumatoid Arthritis (RA) (e.g., seronegative spondyloarthropathy, psoriatic arthritis, Reiter's syndrome, systemic lupus erythematosus, gouty arthritis, or any arthritis with onset prior to age 17 years).
• Known hypersensitivity to adalimumab or its excipients.
• Subject currently uses or plans to use anti-retroviral therapy at any time during the study.
• History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.
• History of invasive infection (e.g., listeriosis and histoplasmosis), human immunodeficiency syndrome (HIV).
• Chronic recurring infections or active Tuberculosis (TB).
• History of moderate to severe congestive heart failure (New York Heart Association (NYHA) class III or IV), recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix.
• Subject received any live vaccine within 3 months prior to study drug administration. - Subject has a history of clinically significant hematologic (e.g., severe anemia, leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis, hepatitis).
• Positive pregnancy test at Screening or Baseline.
• Subject is considered by the investigator, for any reason, to be unsuitable candidate for the study

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (21)

Site Reference ID/Investigator# 75073

Mesa, Arizona, 85202, United States

Location

Site Reference ID/Investigator# 75077

Hemet, California, 92543, United States

Location

Site Reference ID/Investigator# 75076

Wichita, Kansas, 67203, United States

Location

Site Reference ID/Investigator# 75075

Clifton, New Jersey, 07012, United States

Location

Site Reference ID/Investigator# 83133

Philadelphia, Pennsylvania, 19152, United States

Location

Site Reference ID/Investigator# 75074

Charleston, South Carolina, 29406, United States

Location

Site Reference ID/Investigator# 75100

Brussels, 1200, Belgium

Location

Site Reference ID/Investigator# 75101

Liège, 4000, Belgium

Location

Site Reference ID/Investigator# 75104

Brno, 638 00, Czechia

Location

Site Reference ID/Investigator# 76788

Prague, 128 50, Czechia

Location

Site Reference ID/Investigator# 75102

Uherské Hradiště, 686 01, Czechia

Location

Site Reference ID/Investigator# 75103

Zlín, 760 01, Czechia

Location

Site Reference ID/Investigator# 78014

Ratingen, 40882, Germany

Location

Site Reference ID/Investigator# 75079

Caguas, 00725, Puerto Rico

Location

Site Reference ID/Investigator# 75078

Vega Baja, 00693, Puerto Rico

Location

Site Reference ID/Investigator# 76787

Bucharest, 020475, Romania

Location

Site Reference ID/Investigator# 75978

Cluj-Napoca, 400006, Romania

Location

Site Reference ID/Investigator# 76433

Ploieşti, 100337, Romania

Location

Site Reference ID/Investigator# 76934

Banská Bystrica, 97405, Slovakia

Location

Site Reference ID/Investigator# 76935

Senica, 905 01, Slovakia

Location

Site Reference ID/Investigator# 76682

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

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: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2012
• First Posted: October 23, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: June 11, 2014
• Results First Posted: June 11, 2014

Record last verified: 2014-06

Locations

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