Rheumatoid ArthritisPhase 2NCT00069017
Effects of MEDI-522 On Disease Activity and Progression of Joint Damage in Patients With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
A Phase 2 study testing MEDI-522 in people with Rheumatoid Arthritis, run by MedImmune LLC at 40 sites in 2 countries.
Trial summary
To compare, as a preliminary analysis, the effects of MEDI-522 versus placebo at 6 months on disease activity (ACR20) and progression of structural joint damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- MEDI-522
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 40 sitesin 2 countries
- Study dates
- Sep 2003to Apr 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Patients must have none of the following:
- Severe active RA, which in the opinion of the investigator currently requires an alternative form of therapy
- Acute illness at the start of the study
- Evidence of significant active infection, such as fever greater than or equal to 38.0°C (100.5°F)
- Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies
- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
Show all 24Show fewer
- Insulin-dependent diabetes mellitus that is recent-onset or unstable
- Evidence of active or latent tuberculosis, which may include a positive PPD skin test result (greater than or equal to 10 mm induration), unless appropriate INH prophylaxis for tuberculosis previously given; a chest X-ray possibly consistent with tuberculosis; or household contact with a patient with active tuberculosis
- A medical history or evidence of clinically important chronic infection, recurrent (3 or more) infections in the past 6 months requiring antibiotics, or an infection in the past month requiring systemic antibiotics
- Receipt of any investigational drug therapy, except MEDI-522, within 3 months prior to study randomization (use of licensed agents for indications not listed in the package insert is permitted)
- Current or any past therapy with anti-TNF biologic antagonists including etanercept, infliximab, and adalimumab
- Current therapy with cyclosporin A, leflunomide, cyclophosphamide, azathioprine, gold salts, d-penicillamine, mycophenylate mofetil, minocycline or anakinra. These drugs must have been discontinued at least 4 weeks prior to study randomization.
- Prednisone or equivalent at >10 mg per day orally in the 8 weeks before study randomization. Intraarticular, periarticular, or other forms of parenteral injection of corticosteroids are also not permitted in the 8 weeks prior to study randomization.
- History of allergic disease or reactions likely to be exacerbated by any component of MEDI-522
- History of gastrointestinal bleeding (i.e., stool positive for occult blood or overt bleeding) within the previous 6 months
- Known bleeding disorder or significant risk of clinically important abnormal bleeding due to anticoagulant therapy with warfarin or heparin
- Elective surgery planned during the study period through Study Day 413
- Cardiovascular disease that is unstable, such as recent-onset angina, or angina with increasing frequency or severity, or recent myocardial infarction (within past 1 year without definitive corrective surgery such as coronary bypass graft or angioplasty)
- Neurological disease, such as multiple sclerosis, previous stroke, clinically significant cerebrovascular disease, or other forms of organic brain disease that is clinically significant
- Pulmonary, hepatic, renal, or hematological disease that is unstable and progressive, or clinically severe
- Pregnancy (all females, unless surgically sterile or at least one year post-menopausal, must have a negative urine pregnancy test on Study Day 0, prior to dosing)
- Nursing mother
- History of alcohol or drug abuse within past 2 years
- Evidence on physical examination of rheumatoid or other types of vasculitis.
Trial locations and contacts
40 sites in 2 countries.
40 sites in 2 countries
United States29 sites
The Center for Rheumatology
Albany, New York, 12206
Amarillo Center for Clinical Research
Amarillo, Texas, 79124
Arthritis and Rheumatic Disease Specialty
Aventura, Florida, 33180
The University of Alabama at Birmingham
Birmingham, Alabama, 35249-7201
Radiant Research
Dallas, Texas, 75235
Sanford S. Hartman
Decatur, Georgia, 30033
Fayetteville Diagnostic Clinic, Ltd.
Fayetteville, Arkansas, 72703
Centre for Rheumatology, Immunology & Arthritis
Fort Lauderdale, Florida, 33334
Sun Valley Arthritis Center
Glendale, Arizona, 85308
Gundersen Clinic Ltd.
La Crosse, Wisconsin, 54601
Thornton Hospital
La Jolla, California, 92037-0943
Arthritis & Osteoporosis Associates, LLP
Lubbock, Texas, 79410
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792-3244
Ocala Rheumatology Research Center
Ocala, Florida, 34474
Health Research Institute
Oklahoma City, Oklahoma, 73109
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112
Arizona Research & Education
Phoenix, Arizona, 85012
Boling Clinical Trials
Rancho Cucamonga, California, 91730
University of Utah Medical Hospital
Salt Lake City, Utah, 84132
Pacific Arthritis Center Medical Group
Santa Maria, California, 93454
Sarasota Arthritis Research Center
Sarasota, Florida, 34239
The Physician's Clinic of Spokane
Spokane, Washington, 99204
RIMA
St Louis, Missouri, 63131
Arthritis Consultants, Inc.
St Louis, Missouri, 63141
Rheumatology Associates of New Jersey
Teaneck, New Jersey, 07666
University of Arizona
Tucson, Arizona, 85724
Oklahoma Center for Arthritis Therapy and Research Inc.
Tulsa, Oklahoma, 74114
Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
Rheumatology Northwest/Clinical Trials Northwest
Yakima, Washington, 98902
Canada11 sites
Charlton Medical Center
Hamilton, Ontario, L8N 1Y2
MAC Research, Inc.
Hamilton, Ontario, L8N 2B6
K-W Musculoskeletal Research, Inc.
Kitchener, Ontario, N2M 5N6
Rheumatic Disease Center of Montreal
Montreal, Quebec, H3Z 2Z3
The Arthritis Program Research Group Inc.
Newmarket, Ontario, L3Y 3R7
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6
Richmond Health Science Center
Richmond, British Columbia, V7C 5L9
Midtown Medical Center
Saskatoon, Saskatchewan, S7K 0H6
Manitoba Clinic
Winnipeg, Manitoba, R3A 1M1
Arthritis Centre
Winnipeg, Manitoba, R3A 1M4
Centre Inflammatory Arthritis Disease Studies
Winnipeg, Manitoba, R3N OK6
About this study
Official title: A Phase II, Randomized, Double-Blind Study to Evaluate the Effects of MEDI-522, a Humanized MAb to Integrin Alpha V Beta 3, On Disease Activity and Progression of Joint Damage in Pts With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
To compare, as a preliminary analysis, the effects of MEDI-522 versus placebo at 6 months on disease activity (ACR20) and progression of structural joint damage.
Read the detailed description
To compare, as a preliminary analysis, the effects of subcutaneously administered MEDI-522 versus placebo at 6 months on disease activity and progression of structural joint damage in patients with rheumatoid arthritis (RA), who have active disease despite ongoing treatment with methotrexate (MTX) with or without hydroxychloroquine (HCQ) and/or sulfasalazine (SSZ).
- Conditions
- Rheumatoid Arthritis
- Being tested
- MEDI-522, Placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-522Biological
MEDI-522 is formulated in a sterile isotonic solution of 10 mM histidine-HCl at pH 6 containing 100 mg of MEDI-522 protein at a concentration of 100 mg/mL.
PlaceboOther
Placebo for MEDI-522 contains 10 mM histidine-HCl at pH 6, 0.1% Tween-80, 1.5% Mannitol, 4.3 µg/mL Vitamin B12, and 2 µg/mL D\&C Yellow #10.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | MEDI-522 - 4 mg/kg of MEDI-522 (N=200) Receives: Biological: MEDI-522 |
| 2 | Placebo comparator | Placebo (N=100) Receives: Other: Placebo |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2003 (estimated)
- Study startSep 2003
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069017
- Sponsor's protocol ID
- MI-CP100
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2003
- Last updated
- 27 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-Blind Study to Evaluate the Effects of MEDI-522, a Humanized MAb to Integrin Alpha V Beta 3, On Disease Activity and Progression of Joint Damage in Pts With Active Rheumatoid Arthritis Suboptimally Responding to Methotrexate
- ClinicalTrials.gov ID
- NCT00069017
- Acronym / sponsor ID
- MI-CP100
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Study completion
- Apr 2006 (actual)
- First posted
- 17 Sep 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare, as a preliminary analysis, the effects of MEDI-522 versus placebo at 6 months on disease activity (ACR20) and progression of structural joint damage.
Detailed description
To compare, as a preliminary analysis, the effects of subcutaneously administered MEDI-522 versus placebo at 6 months on disease activity and progression of structural joint damage in patients with rheumatoid arthritis (RA), who have active disease despite ongoing treatment with methotrexate (MTX) with or without hydroxychloroquine (HCQ) and/or sulfasalazine (SSZ).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Biological: MEDI-522MEDI-522 - 4 mg/kg of MEDI-522 (N=200) |
| 2 | Placebo comparator | Other: PlaceboPlacebo (N=100) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Severe active RA, which in the opinion of the investigator currently requires an alternative form of therapy
- Acute illness at the start of the study
- Evidence of significant active infection, such as fever greater than or equal to 38.0°C (100.5°F)
- Known or suspected infection with human immunodeficiency virus (HIV) or other evidence of clinically significant immune deficiencies
- Evidence of active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, such as positive HBsAg or positive anti-hepatitis C antibody
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEDI-522MEDI-522 is formulated in a sterile isotonic solution of 10 mM histidine-HCl at pH 6 containing 100 mg of MEDI-522 protein at a concentration of 100 mg/mL. | Biological | 1 |
| PlaceboPlacebo for MEDI-522 contains 10 mM histidine-HCl at pH 6, 0.1% Tween-80, 1.5% Mannitol, 4.3 µg/mL Vitamin B12, and 2 µg/mL D\&C Yellow #10. | Other | 2 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
40 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MEDI-522 in people with Rheumatoid Arthritis, run by MedImmune LLC at 40 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2007.