Rheumatoid ArthritisPhase 1NCT00838565

Phase I Study Of The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of PF-04236921 In Patients With Rheumatoid Arthritis

A Phase 1 study testing dose level 1, dose level 2 and dose level 3 in people with Rheumatoid Arthritis, run by Pfizer at 8 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the safety and tolerability of PF-04236921 administered monthly as three intravenous infusions. Each group of patients will be assigned to a dose level; Safety and tolerability of a low dose level will be required before proceeding to successively higher dose levels. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: dose level 1, dose level 2 and dose level 3
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 41 participants
Where: 8 sitesin 3 countries
Study dates: 20 May 2009to 2 Feb 2012
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Rheumatoid Arthritis on a stable dose of methotrexate
Rheumatoid Arthritis disease activity as assessed by blood tests

Who cannot join

Serious or uncontrolled medical conditions
Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab
Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent

Trial locations and contacts

8 sites in 3 countries.

Country

City, postcode or hospital

8 sites in 3 countries

United States3 sites

Allergy, Asthma, Arthritis, & Lung
Daytona Beach, Florida, 32114
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Millennium Research
Ormond Beach, Florida, 32174

Other trials in United States

South Korea3 sites

Inha University Hospital, Medicine/Rheumatology
Incheon, 400-711
Seoul National University Hospital, Rheumatology, Internal Medicine
Seoul, 110-744
Yonsei University College of Medicine, Severance Hospital, Clinical Trial Center
Seoul, 120-752

Other trials in South Korea

Spain2 sites

Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Clinico Universitario de Santiago
Santiago de Compostela, A Coruña, 15706

Other trials in Spain

About this study

Official title: Phase 1, Randomized, Patient And Investigator-blind, Placebo-controlled Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of Pf-04236921 In Patients With Rheumatoid Arthritis Receiving Methotrexate

Read the detailed description

Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.

Conditions: Rheumatoid Arthritis
Being tested: Placebo, dose level 1, dose level 2, dose level 3, dose level 4
Keywords: Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921
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 infusion on three consecutive months
dose level 1Drug
intravenous infusion on three consecutive months
dose level 2Drug
intravenous infusion on three consecutive months
dose level 3Drug
intravenous infusion on three consecutive months
dose level 4Drug
intravenous infusion on 3 consecutive months

Study groups in NCT00838565
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
PF-04236921	Experimental	Not described Receives: Drug: dose level 1; Drug: dose level 2; Drug: dose level 3; Drug: dose level 4

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Measured: Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)
Number of Participants With Positive Anti-drug Antibodies Response
Measured: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
Maximum Observed Serum Concentration (Cmax): Day 1
Measured: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1
Measured: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Measured: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Maximum Observed Serum Concentration (Cmax): Day 28
Measured: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28
Measured: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Measured: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Maximum Observed Serum Concentration (Cmax): Day 56
Measured: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56
Measured: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Measured: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
Serum Decay Half-Life (t1/2): Day 56
Serum decay half-life is the time measured for the serum concentration to decrease by one half.
Measured: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 20092 Feb 2012

First posted6 Feb 2009 (estimated)
Study start20 May 2009
Primary completion2 Feb 2012
Study completion2 Feb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 PfizerThe 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00838565
Sponsor's protocol ID: B0151002
Other IDs: 2009-009866-15, 2009
Status last verified: Mar 2018
First submitted: 4 Feb 2009
Last updated: 2 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
PubMed 29776017

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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Active, not recruitingPhase 2
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Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 1, Randomized, Patient And Investigator-blind, Placebo-controlled Study To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics Of Multiple Intravenously Administered Doses Of Pf-04236921 In Patients With Rheumatoid Arthritis Receiving Methotrexate
ClinicalTrials.gov ID: NCT00838565
Acronym / sponsor ID: B0151002
Conditions: Rheumatoid Arthritis
Keywords: Safety and tolerability Pharmacokinetics Pharmacodynamics PF-04236921
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 20 May 2009 (actual)
Primary completion: 2 Feb 2012 (actual)
Study completion: 2 Feb 2012 (actual)
First posted: 6 Feb 2009 (estimated)
Results: Posted 2 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Safety and Tolerability and Pharmacokinetic/Pharmacodynamic assessment of inflammation-related biomarkers.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
PF-04236921	Experimental	Drug: dose level 1, Drug: dose level 2, Drug: dose level 3, Drug: dose level 4

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Rheumatoid Arthritis on a stable dose of methotrexate
Rheumatoid Arthritis disease activity as assessed by blood tests

Key exclusion criteria (3 listed)

Serious or uncontrolled medical conditions
Current or recent treatment with disease-modifying drugs other than methotrexate including but not limited to leflunomide, sulfasalazine, etanercept, infliximab, adalimumab, abatacept, rituximab
Current oral glucocorticoid dose of more than 10 mg/d prednisone equivalent

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 infusion on three consecutive months	Drug	Placebo
dose level 1intravenous infusion on three consecutive months	Drug	PF-04236921
dose level 2intravenous infusion on three consecutive months	Drug	PF-04236921
dose level 3intravenous infusion on three consecutive months	Drug	PF-04236921
dose level 4intravenous infusion on 3 consecutive months	Drug	PF-04236921

Primary outcome

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)
An AE was any untoward medical occurrence in a participant who received study medication without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study medication and up to 28 days after last dose or until serum PF-04236921 concentrations were below the LLOQ that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Number of Participants With Positive Anti-drug Antibodies Response
Time frame: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624)
Maximum Observed Serum Concentration (Cmax): Day 1
Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1
Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 1
Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Maximum Observed Serum Concentration (Cmax): Day 28
Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 28
Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 28
Time frame: Day 28: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Maximum Observed Serum Concentration (Cmax): Day 56
Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Time to Reach Maximum Observed Serum Concentration (Tmax): Day 56
Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-168)]: Day 56
Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours post-dose
AUC (0-168) = Area under the serum concentration versus time curve from time zero (pre-dose) to 168 hours (0-168).
Serum Decay Half-Life (t1/2): Day 56
Time frame: Day 56: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours, 672 hours post-dose
Serum decay half-life is the time measured for the serum concentration to decrease by one half.

Results and safety

Results posted to the registry on 2 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	9	9
PF-04236921 1 mg	7	4
PF-04236921 10 mg	6	5
PF-04236921 30 mg	6	6
PF-04236921 100 mg	6	6
PF-04236921 250 mg	7	5

Primary outcome: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame: Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624). Number. Unit: participants

Measure	Placebo n = 9	PF-04236921 1 mg n = 6	PF-04236921 10 mg n = 6	PF-04236921 30 mg n = 6	PF-04236921 100 mg n = 6	PF-04236921 250 mg n = 7
AEs	9	4	4	6	6	5
SAEs	0	0	0	2	1	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication.

Primary outcome: Number of Participants With Positive Anti-drug Antibodies Response

Time frame: Day 1, 28, 56, 84, 174, 354, End of Study (Day 624). Number. Unit: participants

Measure	PF-04236921 1 mg n = 6	PF-04236921 10 mg n = 6	PF-04236921 30 mg n = 6	PF-04236921 100 mg n = 6	PF-04236921 250 mg n = 7
Day 1	0	0	0	0	0
Day 28	0	0	0	0	0
Day 56	0	0	0	0	0
Day 84	0	0	0	0	0
Day 174	0	0	0	0	0
Day 354	–	0	0	0	0
End of Study	0	0	0	0	0

Population analysed: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'n' signifies those participants who were evaluable for this measure at specified time points for each arm, respectively.

Primary outcome: Maximum Observed Serum Concentration (Cmax): Day 1

Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose. Geometric mean (Standard Deviation). Unit: nanogram per milliliter (ng/mL)

Measure	PF-04236921 1 mg n = 6	PF-04236921 10 mg n = 6	PF-04236921 30 mg n = 6	PF-04236921 100 mg n = 6	PF-04236921 250 mg n = 7
Value	421.6 (162.89)	4631 (1429.9)	11320 (2167.2)	42290 (7883.0)	66280 (59405)

Population analysed: Pharmacokinetic (PK) parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.

Primary outcome: Time to Reach Maximum Observed Serum Concentration (Tmax): Day 1

Time frame: Day 1: Pre-dose (0 hour), 15 minutes, 168 hours, 336 hours post-dose. Median (Full Range). Unit: days

Measure	PF-04236921 1 mg n = 6	PF-04236921 10 mg n = 6	PF-04236921 30 mg n = 6	PF-04236921 100 mg n = 6	PF-04236921 250 mg n = 7
Value	0.0521 (0.0521 to 0.0528)	0.0521 (0.0521 to 0.0521)	0.0521 (0.0521 to 0.0521)	0.0521 (0.0278 to 0.0521)	0.0521 (0.0521 to 0.0528)

Population analysed: PK parameter analysis population included all enrolled and treated participants who had at least 1 of the PK parameters of interest.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 9 (0%)	9 of 9 (100%)	Not reported
PF-04236921 1 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
PF-04236921 10 mg	0 of 6 (0%)	4 of 6 (66.7%)	Not reported
PF-04236921 30 mg	2 of 6 (33.3%)	6 of 6 (100%)	Not reported
PF-04236921 100 mg	1 of 6 (16.7%)	6 of 6 (100%)	Not reported
PF-04236921 250 mg	0 of 7 (0%)	5 of 7 (71.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29776017Li C, Shoji S, Beebe J. Pharmacokinetics and C-reactive protein modelling of anti-interleukin-6 antibody (PF-04236921) in healthy volunteers and patients with autoimmune disease. Br J Clin Pharmacol. 2018 Sep;84(9):2059-2074. doi: 10.1111/bcp.13641. Epub 2018 Jun 25.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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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.

Pfizer CT.gov Call Center study director

Pfizer

8 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing dose level 1, dose level 2 and dose level 3 in people with Rheumatoid Arthritis, run by Pfizer at 8 sites in 3 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 2 inclusion and 3 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 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, South Korea, Spain. 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?

Yes. Results are posted in the registry (first posted 2 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to 28 days after last dose of study medication or until serum PF-04236921 concentrations below the LLOQ (up to Day 624)). The study lists 12 primary outcomes in all. 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 NCT00838565, 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 2 Nov 2018.