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A Partially Blinded, Randomized, Multi-Center, Phase IV Trial to Evaluate Mechanism of Action of Anti-TNF Agents in Rheumatoid Arthritis


Phase 4
18 Years
75 Years
Open (Enrolling)
Both
Rheumatoid Arthritis

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Trial Information

A Partially Blinded, Randomized, Multi-Center, Phase IV Trial to Evaluate Mechanism of Action of Anti-TNF Agents in Rheumatoid Arthritis


RA is characterized by persistent inflammation of peripheral joints, causing pain,
stiffness, swelling, and warmth. Over the past 10 years, advancements in biotechnology have
revolutionized RA therapeutics with biologically-derived immunomodulating compounds.
TNF-alpha inhibitors constitute the largest class of these new biologic therapies. The
purpose of this study is to determine the effectiveness two TNF inhibitors, etanercept and
adalimumab, on memory B lymphocytes (B-cells) in the peripheral blood of participants with
RA.

This study will last 24 weeks. Participants will be randomized into one of two arms.
Participants in Arm 1 will receive a subcutaneous injection of etanercept once every week
for 24 weeks. Participants in Arm 2 will receive a subcutaneous injection of adalimumab once
every 2 weeks for 24 weeks.

This study consists of seven study visits after randomization and will occur at study entry
and Weeks 4, 8, 12, 16, 20 and 24. Blood collection will occur at all study visits. A
written participant assessment, vital signs, and physical exam will occur at study entry and
Weeks 12 and 24. Follow-up calls to assess safety are scheduled for Weeks 4, 8, 16, and 20.

Additionally, participants will be offered the opportunity to enter one of four sub-studies
as mentioned in the brief summary above: B Cell Kinetic Sub-Study, Vaccine Response
Sub-Study, Tonsil Biopsy Sub-Study, and Synovial Biopsy Sub-Study. More information on these
sub-studies can be found in the protocol.


Inclusion Criteria:



- Diagnosis of RA. More information on this criterion can be found in the protocol.

- Disease duration as defined from the onset of symptoms of at least 3 months prior to
study entry

- Active RA with DAS28 > 4.4, clinically requiring the addition of anti-TNF therapy

- Stable dose of MTX between 7.5 mg and 25 mg weekly for at least 8 weeks prior to
study entry

- Able and willing to self-administer subcutaneous injections or have available
qualified person(s) or caregiver to administer subcutaneous injections

- For females, agree to use accepted methods of contraception during the duration of
the study and for 150 days after study completion. More information on this criterion
can be found in the protocol.

Exclusion Criteria:

- Positive PPD (> 5 mm induration regardless of prior Bacille Calmette Guerin [BCG]
vaccine administration) without evidence of ongoing treatment for at least 30 days or
completed treatment

- History of positive PPD or chest x-ray findings indicative of prior TB infection,
without documentation of either treatment for TB infection or chemoprophylaxis for TB
exposure

- Prednisone dose > 10 mg/day (or equivalent dose of another corticosteroid) within 30
days prior to study entry

- Definitive diagnosis of another autoimmune disease that may require immunosuppression
for treatment. More information on this criterion can be found in the protocol.

- Concomitant use of DMARDSs. More information on this criterion can be found in the
protocol.

- Any immunosuppressive therapy other than MTX, NSAIDs, or corticosteroids. More
information on this criterion can be found in the protocol.

- Current or previous use of any biologic agent

- Presence of open leg ulcers

- Chronic or persistent infection that might be worsened by immunosuppressive
treatment. More information on this criterion can be found in the protocol.

- Active infection or severe infections requiring hospitalization or treatment with IV
antibiotics, IV antivirals, or IV antifungals within 30 days prior to study entry

- Received oral antibiotics, antivirals, or antifungals within 14 days prior to study
entry

- Certain abnormal laboratory values. More information on this criterion can be found
in the protocol.

- Any medical condition that, in the opinion of the investigator, would interfere with
the study

- History of malignancy other than treated localized carcinoma in situ of the cervix or
adequately treated non-metastatic squamous or basal cell skin carcinoma within 10
years prior to study entry

- Any Investigational agent within the earlier of 4 weeks or 5 half-lives prior to
study entry

- History of drug or alcohol abuse within 6 months prior to study entry

- Known allergy or hypersensitivity to study products

- Inability or unwillingness to follow the protocol

- Any condition or treatment that, in the opinion of the investigator, places the
participant at an unacceptable risk

- Pregnant or breastfeeding

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

Change in memory B-cells in peripheral blood

Outcome Time Frame:

Throughout study

Safety Issue:

No

Principal Investigator

Jennifer A. Anolik, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Rochester

Authority:

United States: Federal Government

Study ID:

DAIT ARA06

NCT ID:

NCT00837434

Start Date:

March 2009

Completion Date:

September 2013

Related Keywords:

  • Rheumatoid Arthritis
  • Arthritis
  • Arthritis, Rheumatoid

Name

Location

University of AlabamaBirmingham, Alabama  
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of California, San FranciscoSan Francisco, California  94143
University of RochesterRochester, New York  14642
University of ChicagoChicago, Illinois  60637
Yale University School MedicineNew Haven, Connecticut  06519
Feinstein Institute for Medical ResearchManhassett, New York  11030