A Study of Adalimumab When Added to Inadequate Standard Anti-rheumatic Therapy in Patients With Active Rheumatoid Arthritis

NCT01231321 | Completed Phase 3 Results DMC

• 1 other identifier: W06-406
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

A total of 100 participants diagnosed with active rheumatoid arthritis were enrolled at 5 sites in Russia. Adalimumab was administered by subcutaneous injection every other week, with dose escalation to weekly dosing available for participants not receiving concomitant disease-modifying antirheumatic drugs (DMARDs) who did not achieve American College of Rheumatology 20 (ACR20) criteria after 12 weeks of treatment. Efficacy and safety measurements were performed throughout the study.

Conditions

Rheumatoid Arthritis

Keywords

Adalimumab added to inadequate standard anti-rheumatic therapy in patients with active Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (4)

• Frequency of Adverse Events

  Serious adverse events were collected from the time of informed consent, and nonserious adverse events were collected from the time of first dose of adalimumab, until 70 days after the last injection of adalimumab. Refer to the Reported Adverse Events section of this results disclosure for specific adverse events reported. Note: Severe events considerably interfered in patients' usual activities and may have been life-threatening. Serious events were life-threatening; resulted in hospitalization, congenital anomalies, or disability; or required intervention to prevent seriousness.

  Up to 34 weeks (24 week study treatment plus 70-day follow-up period)

• Changes of Physical Examination

  Physical examination findings were compared between Baseline and Week 24, and changes were recorded (Normal at Baseline to Abnormal at Week 24; or Abnormal at Baseline to Normal at Week 24). Physical examination criteria (normal vs. abnormal) were at the clinical judgement of the examining physician. Significant changes in physical examination from Baseline were considered to be adverse events.

  Baseline and 24 weeks

• Deviation From Normal Laboratory Ranges

  Laboratory values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note abbreviations used in table: Alk. phosphatase = alkaline phosphatase, ALT = alanine aminotransferase, AST = aspartate aminotransferase, ESR = erythrocyte sedimentation rate

  24 weeks

• Vital Sign Values

  Vital signs values were assessed for values above and below the normal (reference) ranges used by the central laboratory. Note, in table, BP = blood pressure.

  24 weeks

Secondary Outcomes (1)

• Change in Disease Activity Score (DAS28) Compared With Baseline

  Baseline and 24 weeks

Study Arms (1)

adalimumab

EXPERIMENTAL

Adalimumab / pre-filled syringe 40 mg/0.8 ml

Drug: adalimumab

Interventions

adalimumab DRUG

Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.

Also known as: ABT-D2E7, Humira

adalimumab

Eligibility Criteria

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

You may qualify if:

• Males and females \>= 18 years of age.
• A negative pregnancy test (human chorionic gonadotropin in serum samples) for women of childbearing potential prior to start of study treatment.
• Female subject is either not of childbearing potential, defined as postmenopausal (at least 1 year since last menses) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy), or is of childbearing potential and practicing one of the following methods of birth control throughout the study and for 150 days after study completion:
• Condoms, sponge, foams, jellies, diaphragm or intrauterine device.
• Contraceptives (oral, parenteral, patch) for three months prior to study drug administration.
• A vasectomized partner.
• American College of Rheumatology criteria for diagnosis of rheumatoid arthritis for at least 6 months.
• Subjects must meet the following three criteria:
• Disease Activity Score (28 joints) more or equal 3.2 (at Baseline only)
• At least 6 swollen joints out of the 66 assessed
• At least 8 tender joints out of the 68 assessed
• Subjects must have a C-reactive protein \>= 1.5mg/dL or erythrocyte sedimentation rate \>= 28 mm/1h.
• Unsatisfactory response or intolerance to prior disease modifying anti-rheumatic drugs (must have failed at least 1 disease modifying anti-rheumatic drug).
• Able and willing to administer subcutaneous injections.
• Able and willing to give written informed consent and to comply with the requirements of the study protocol.

You may not qualify if:

• Prior treatment with alkylating agents such as cyclophosphamide or chlorambucil within at least 5 years before enrollment.
• Prior treatment with intravenous immunoglobulin or any investigational agent "chemical" in nature within 30 days, or 5 half lives of the product, whichever is longer.
• Prior treatment with cyclosporine within the last 6 months.
• Prior treatment with investigational biologic therapy.
• Subject has chronic arthritis diagnosis before the age 17 years.
• Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study).
• History of an allergic reaction or significant sensitivity to the constituents of study drug (adalimumab).
• Treatment within the last 2 months with approved biologic therapy (e.g. infliximab) prior to Baseline.
• Prior treatment with total lymphoid irradiation.
• History of cancer or lymphoproliferative disease other than a successfully and completely treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix.
• History of or current acute inflammatory joint disease of origin other than rheumatoid arthritis, e.g. mixed connective tissue disease, systemic lupus erythematosus etc.
• History of uncontrolled diabetes, unstable ischemic heart disease, congestive heart failure (New York Heart Association III-IV), active peptic ulcer disease, recent stroke (within 3 months) and any other condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.
• Subject is known to have immune deficiency, history of positive human immunodeficiency virus status or is immunocompromised.
• Persistent chronic infection, or severe infections requiring hospitalization or treatment with intravenous antibiotics within 30 days, or oral antibiotics within 14 days prior to enrollment.
• Female subjects who are pregnant or breast-feeding or is considering becoming pregnant during the study or for 150 days after the last dose of study medication.

Sponsors & Collaborators

• Abbott: lead

Study Sites (5)

Site Ref # / Investigator 17682

Kazan', 420095, Russia

Location

Site Ref # / Investigator 7417

Moscow, 115522, Russia

Location

Site Ref # / Investigator 17681

Moscow, 117513, Russia

Location

Site Ref # / Investigator 7401

Moscow, 119049, Russia

Location

Site Ref # / Investigator 18081

Saint Petersburg, 191015, Russia

Location

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: Abbott

800-633-9110

Study Officials

• Konstantin Gudkov, MD

  Abbott

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: December 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 26, 2011
• Results First Posted: March 24, 2011

Record last verified: 2011-04

Locations

RU (5)