Arthritis, RheumatoidPhase 2ALD518-003NCT00867516
Safety, Efficacy and Pharmacokinetics Study of ALD518 in Patients With Active Rheumatoid Arthritis
A Phase 2 study testing ALD518 and Infusion without ALD518' in people with Arthritis, Rheumatoid, run by CSL Behring at 26 sites in 6 countries.
Trial summary
The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- ALD518 and Infusion without ALD518'
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 26 sitesin 6 countries
- Study dates
- Oct 2008to Dec 2009
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Active Rheumatoid Arthritis for at least 16 weeks duration
- Have a C-reactive protein (CRP) of ≥ 10mg/L
- Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months
Who cannot join
- Arthritis onset prior to 16 years old
- Received any biologic therapy in the previous 12 months
- A history of or currently have active tuberculosis
- Any clinically significant concurrent medical condition
Trial locations and contacts
26 sites in 6 countries.
26 sites in 6 countries
Russia10 sites
Regional Clinical Hospital of War Veterans
Kemerovo, 650099
Institute of Clinical and Experimental Lymphology
Novosibirsk, 630117
Ryazan Regional Clinical Cardiologic Dispensary
Ryazan, 390026
Saint Petersburg Medical Academy of Postgraduate Study
Saint Petersburg, 191015
Saint-Petersburg State Medical Academy named after I. I. Mechnikov
Saint Petersburg, 195067
City Hospital #26
Saint Petersburg, 196247
Regional War Veterans' Hospital
Saratov, 410002
Tomsk Regional Clinical Hospital
Tomsk, 634063
Tula Regional Clinical Hospital
Tula, 300053
Clinical Hospital of Emergency Care named after N.V. Solovyev
Yaroslavl, 150003
India5 sites
St. John's Medical College Hospital
Bangalore, 560 034
Chanre Rheumatology and Immunology Center and Research
Malleshwaram, Bangalore, 560 003
KLE Society Hospital and Medical Research Centre
Nehru Nagar, Belgaum, 590 010
Sushrut Hospital, Research Centre & Post Graduate Institute of Orthopaedics
Ramadaspeth, Nagpur, 440 010
Krishna Institute of Medical Sciences Ltd.
Secunderabad, 500 003
Poland5 sites
Miriada Center Private Clinic of Professor Sierakowski
Bialystok, 15-297
Nonpublic Centre of Medical Care Reumed
Lublin, 26-607
NOVAMED - Medical Center of Poznan
Poznan, 60-773
Provincional Rheumatological Complex named after Dr Jadwiga Titz-Kosko
Sopot, 81-759
Szezecin Clinic of Rheumatology and Internal Diseases
Szczecin, 71-252
Canada2 sites
K-W Musculoskeletal Research, Inc.
Kitchener, Ontario, N2M 5N6
Rheumatology Research Associates
Ottawa, Ontario, KIH IA2
Georgia2 sites
V. Tsitlanadze Scientific Practical Centre of Rheumatology
Tbilisi, 0102
Medulla Chemotherapy and Immunotherapy Clinic
Tbilisi, 0186
Serbia2 sites
Institute of Rheumatology
Belgrade, 11000
Institute for Rehabilitation and Treatment Niska Banja
Niška Banja, 18205
About this study
Official title: A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.
Read the detailed description
This will be a phase II, parallel-group, double-blind, randomized, placebo-controlled study of ALD518 in patients with active RA with an inadequate response to methotrexate.
Enrolled patients will be screened within a 4-week period (Day -35 to -7). within a 12-day period (Day-14 to -3) before initial dosing on Day 1 patients will be randomized to one of the following four treatment groups:
Group A: 2x ALD518 80 mg Group B: 2x ALD518 160 mg Group C: 2x ALD518 320 mg Group D: 2x placebo
In all treatment groups patients will continue to take a stable dose of methotrexate.
There will be a total of 11 visits. The total duration of the patient study participation will be approximately 16 weeks (excluding the screening period).
- Conditions
- Arthritis, Rheumatoid
- Being tested
- ALD518, Infusion without ALD518'
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALD518Biological
Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8
Infusion without ALD518'Biological
250 cc Normal saline IV over one hour Weeks 1 and 8.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | ALD518 80 mg Receives: Biological: ALD518 |
| 2 | Experimental | ALD518 160 mg Receives: Biological: ALD518 |
| 3 | Experimental | ALD518 320 mg Receives: Biological: ALD518 |
| 4 | Placebo comparator | No ALD518 Receives: Biological: Infusion without ALD518' |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of AEs and SAEs during the study
Measured: During entire length of study
Secondary outcomes (1)
To evaluate the difference in treatment with ALD518 relative to treatment with placebo in the proportion of patients achieving a 20% improvement in ACR response (ACR20) at Week 12
Measured: 12 weeks after Dose 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionJun 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Smith, MD, FRCP, Study director, Alder BioPharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00867516
- Sponsor's protocol ID
- ALD518-CLIN-003
- Acronym
- ALD518-003
- Status last verified
- Sep 2017
- First submitted
- 20 Mar 2009
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Safety, Efficacy, and Pharmacokinetics of 80,160 and 320mg ALD518 Versus Placebo Administered as Multiple IV Infusions to Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Methotrexate
- ClinicalTrials.gov ID
- NCT00867516
- Acronym / sponsor ID
- ALD518-003 / ALD518-CLIN-003
- Conditions
- Arthritis, Rheumatoid
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Oct 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 23 Mar 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.
The purpose of this study is to determine the safety and efficacy of ALD518 in three different doses in patients who have not had an adequate response to methotrexate.
Detailed description
This will be a phase II, parallel-group, double-blind, randomized, placebo-controlled study of ALD518 in patients with active RA with an inadequate response to methotrexate.
Enrolled patients will be screened within a 4-week period (Day -35 to -7). within a 12-day period (Day-14 to -3) before initial dosing on Day 1 patients will be randomized to one of the following four treatment groups:
Group A: 2x ALD518 80 mg Group B: 2x ALD518 160 mg Group C: 2x ALD518 320 mg Group D: 2x placebo
In all treatment groups patients will continue to take a stable dose of methotrexate.
There will be a total of 11 visits. The total duration of the patient study participation will be approximately 16 weeks (excluding the screening period).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: ALD518ALD518 80 mg |
| 2 | Experimental | Biological: ALD518ALD518 160 mg |
| 3 | Experimental | Biological: ALD518ALD518 320 mg |
| 4 | Placebo comparator | Biological: Infusion without ALD518'No ALD518 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Active Rheumatoid Arthritis for at least 16 weeks duration
- Have a C-reactive protein (CRP) of ≥ 10mg/L
- Have a stable dose of methotrexate (≥ 10mg/week) for at least 3 months
Key exclusion criteria (4 listed)
- Arthritis onset prior to 16 years old
- Received any biologic therapy in the previous 12 months
- A history of or currently have active tuberculosis
- Any clinically significant concurrent medical condition
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 |
|---|---|---|
| ALD518Two doses of ALD518, each given in an infusion of normal saline, IV over 1 hour, at Weeks 1 and 8 | Biological | 1, 2, 3 |
| Infusion without ALD518'250 cc Normal saline IV over one hour Weeks 1 and 8. | Biological | 4 |
Primary outcome
Incidence and severity of AEs and SAEs during the study
Time frame: During entire length of study
1 secondary outcome
To evaluate the difference in treatment with ALD518 relative to treatment with placebo in the proportion of patients achieving a 20% improvement in ACR response (ACR20) at Week 12
Time frame: 12 weeks after Dose 1
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 9 Jul 2020.
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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.
Jeffrey Smith, MD, FRCP study director
Alder BioPharmaceuticals
26 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALD518 and Infusion without ALD518' in people with Arthritis, Rheumatoid, run by CSL Behring at 26 sites in 6 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 3 inclusion and 4 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 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites in Russia, India, Poland, Canada, Georgia and 1 more country. 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.
What does the primary outcome measure?
Incidence and severity of AEs and SAEs during the study (time frame: During entire length of study). It is what the study was designed to measure, not a finding.
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 9 Jul 2020.