The SPECTRA Study

NCT00537667 | Terminated Phase 2

• 1 other identifier: 20000211
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to compare IL-1ra and the combination of IL-1ra and PEGsTNF-RI with respect to their ability to reduce inflammation and bone and cartilage destruction in the synovium of subjects with rheumatoid arthritis.

Conditions

Rheumatoid Arthritis

Keywords

IL-1ra; PEG sTNF-RI; Synovial biopsy; Inflammation; Bone and Cartilage Destruction; Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Primary efficacy endpoint is the change from baseline at weeks 4, 26 and 52 in levels of select markers of inflammation (CD3 and CD 68) and destruction (MMP-1 and TIMP-1) in the synovium

  up to 52 weeks

• Primary safety endpoint is the crude and exposure adjusted subject incidence and nature, frequency, severity, relationship to treatment, and outcome of all adverse events

  up to 52 weeks

Secondary Outcomes (2)

• Secondary efficacy endpoints are change from baseline at week 4 and 52 in selected markers of bone and cartilage degradation and inflammation

  up to 52 weeks

• Secondary safety endpoints are changes from baseline in laboratory parameters

  up to 52 weeks

Study Arms (2)

A

ACTIVE COMPARATOR

anakinra

Drug: anakinra

B

EXPERIMENTAL

anakinra and PEGsTNF-R1

Drug: anakinra and PEG sTNF-R1

Interventions

anakinra DRUG

anakinra

A

anakinra and PEG sTNF-R1 DRUG

anakinra and PEG sTNF-R1

B

Eligibility Criteria

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

You may qualify if:

• Diagnosed with RA as determined by American College of Rheumatology (ACR) criteria (Appendix C)
• Disease duration of no less than 12 weeks of diagnosis confirmed by physician and source documentation
• Disease duration \< 10 years
• Active RA at baseline as defined by a minimum of 6 or more swollen joints and 9 or more tender/painful joints (based on a 66/68-joint count excluding distal interphalangeal joints) at screening and baseline,
• And
• C-reactive protein (CRP) \> 2 mg/dL at screening.
• Have active clinical synovitis in the knee as determined by the investigator based on clinical evaluation
• years of age or older
• Men or non-pregnant (negative serum HCG at screening unless surgically sterile or postmenopausal), non-breast-feeding women may be enrolled. Females of childbearing potential and males must use adequate contraceptive precautions as determined by the principal investigator.
• Subjects that have taken any DMARD for less than 3 months must not have taken DMARDs within 4 weeks prior to screening. Subjects that have taken any DMARD for longer than 3 months must not have taken DMARDs within 6 months of screening.
• Subject's doses of NSAIDs and oral corticosteroids (10 mg/day of prednisone or equivalent) must have been kept stable for 4 weeks before screening
• Subjects must not have had intrarticular injections in the joint that will be arthroscoped for at least 3 months prior to screening.
• Before any study specific procedure or screening is done, the subject or legally acceptable representative must give informed consent for participation in the study (see Section 12.2). Before buccal smears and blood samples are taken for genetic testing, the subject or legally acceptable representative must give informed consent for use of those samples for genetic testing (see Section 12.2).

You may not qualify if:

• ACR functional class IV or American Rheumatology Association anatomical stage IV (see Appendix C)
• Disease duration \>10 years
• Diagnosed with the following:
• Felty's syndrome
• Advanced or uncontrolled Diabetes Mellitus (defined as: HbA1c \> 8%, peripheral neuropathy, renal/retinal involvement, or vascular disorders)
• Malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix, within the past five years
• Any other major chronic inflammatory disease or syndrome (e.g., psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease, fibromyalgia that required treatment in the last year)
• Any uncontrolled, clinically significant systemic disease
• Pre-existing or recent onset central nervous system demyelinating disorders
• Significant hematologic abnormalities
• A history of drug or alcohol abuse within the previous 24 weeks
• Known to be hepatitis B surface antigen, hepatitis C virus or Human Immunodeficiency Virus positive
• Any disorder that compromises ability to give informed consent for participation in this study
• Is expected to require a major surgical operation while on study that would interfere with the collection of the required assessments.
• Has an infection requiring systemic anti-infective therapy, open wounds, or has developed frequent acute or chronic infections during the past 12 weeks.

Sponsors & Collaborators

• Amgen: lead

Related Links

• Notice regarding posted summaries of trial results
• To access clinical trial results information click on this link
• FDA-approved Drug Labeling
• AmgenTrials clinical trials website

MeSH Terms

Conditions

Arthritis, Rheumatoid; Inflammation

Interventions

Interleukin 1 Receptor Antagonist Protein

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 27, 2007
• First Posted: October 1, 2007
• Study Start: August 1, 2001
• Primary Completion: March 1, 2003
• Study Completion: June 1, 2003
• Last Updated: November 26, 2009

Record last verified: 2008-12