Rheumatoid ArthritisPhase 1NCT00888745
A Study of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
A Phase 1 study testing PRO283698 in people with Rheumatoid Arthritis, run by Genentech, Inc. at 12 sites in 2 countries.
Trial summary
This is a Phase I multicenter study that will be conducted in the United States and Europe. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- PRO283698
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 12 sitesin 2 countries
- Study dates
- May 2009to Jun 2010
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA diagnosed according to the American College of Rheumatology (ACR)
Who cannot join
- Female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
- Clinically significant abnormal ECG
- History of anaphylactic reactions
- Positive hepatitis C antibody or hepatitis B surface antigen
- Positive serology for human immunodeficiency virus (HIV) by quantitative polymerase chain reaction
- A history of an autoimmune disease other than RA (other than secondary Sjogren syndrome)
Show all 13Show fewer
- Significant systemic involvement of RA, including vasculitis, pulmonary fibrosis, or Felty syndrome
- Malignancy, or prior malignancy, other than non-melanoma skin cancer, or cervical carcinoma in situ that has been resected
- Recent administration of a live, attenuated vaccine, or anticipation that such a live attenuated vaccine will be required during the study or within 60 days after the last dose
- Concomitant therapy with a biologic agent
- Recent exposure to any investigational agent
- Any current or recent signs or symptoms of infection requiring parenteral antibiotic administration
- Hospitalization for a clinically relevant event within the 4 weeks prior to screening
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
Investigational Site
Anniston, Alabama, 36207
Investigational Site
Duncansville, Pennsylvania, 16635
Investigational Site
Frederick, Maryland, 21702
Investigational Site
Idaho Falls, Idaho, 83404
Investigational Site
Indianapolis, Indiana, 46227
Investigational Site
Oklahoma City, Oklahoma, 73103
Investigational Site
Orlando, Florida, 32804
Investigational Site
Ormond Beach, Florida, 32174
Investigational Site
Palm Harbor, Florida, 34684
Hungary3 sites
Investigational Site
Budapest, 1027
Investigational Site
Debrecen, 4043
Investigational Site
Szeged, 6720
About this study
Official title: A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
This is a Phase I multicenter study that will be conducted in the United States and Europe.
- Conditions
- Rheumatoid Arthritis
- Being tested
- placebo, PRO283698
- Keywords
- RA
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Intravenous and subcutaneous ascending dose
PRO283698Drug
Intravenous and subcutaneous ascending dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: PRO283698 |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of PRO283698 assessed through the incidence of adverse events
Measured: Through study completion or early study discontinuation
Secondary outcomes (1)
Pharmacokinetic parameters
Measured: Following study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- June Lee, M.D., Study director, Genentech, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888745
- Sponsor's protocol ID
- []4623g
- Status last verified
- Nov 2010
- First submitted
- 27 Apr 2009
- Last updated
- 1 Dec 2010
- Results posted
- No
Publications
Emu B, Luca D, Offutt C, Grogan JL, Rojkovich B, Williams MB, Tang MT, Xiao J, Lee JH, Davis JC. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin alpha: results of a phase I randomized, placebo-controlled trial. Arthritis Res Ther. 2012 Jan 8;14(1):R6. doi: 10.1186/ar3554.
PubMed 22225620
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Pharmacokinetics of PRO283698 in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT00888745
- Acronym / sponsor ID
- []4623g
- Conditions
- Rheumatoid Arthritis
- Keywords
- RA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- First posted
- 28 Apr 2009 (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.
This is a Phase I multicenter study that will be conducted in the United States and Europe.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: PRO283698 |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- RA diagnosed according to the American College of Rheumatology (ACR)
Key exclusion criteria (13 listed)
- Female patients who are pregnant, plan to become pregnant during the study, or are breastfeeding
- Clinically significant abnormal ECG
- History of anaphylactic reactions
- Positive hepatitis C antibody or hepatitis B surface antigen
- Positive serology for human immunodeficiency virus (HIV) by quantitative polymerase chain reaction
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 |
|---|---|---|
| placeboIntravenous and subcutaneous ascending dose | Drug | 2 |
| PRO283698Intravenous and subcutaneous ascending dose | Drug | 1 |
Primary outcome
Safety and tolerability of PRO283698 assessed through the incidence of adverse events
Time frame: Through study completion or early study discontinuation
1 secondary outcome
Pharmacokinetic parameters
Time frame: Following study drug administration
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 1 Dec 2010.
- Derived from this study: PubMed 22225620Emu B, Luca D, Offutt C, Grogan JL, Rojkovich B, Williams MB, Tang MT, Xiao J, Lee JH, Davis JC. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin alpha: results of a phase I randomized, placebo-controlled trial. Arthritis Res Ther. 2012 Jan 8;14(1):R6. doi: 10.1186/ar3554.
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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.
June Lee, M.D. study director
Genentech, Inc.
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRO283698 in people with Rheumatoid Arthritis, run by Genentech, Inc. at 12 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 1 inclusion and 13 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 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Hungary. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
What does the primary outcome measure?
Safety and tolerability of PRO283698 assessed through the incidence of adverse events (time frame: Through study completion or early study discontinuation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00888745, which also lists 1 linked publication.
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 1 Dec 2010.