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Rheumatoid ArthritisPhase 1/2NCT01990157

Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis

A Phase 1/2 study testing TAB08 in people with Rheumatoid Arthritis, run by Theramab LLC at 2 sites in Russia.

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 is in two stages: Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not enough effective. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Rheumatoid Arthritis
What is being tested?
TAB08
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
2 sitesRussia
Study dates
Nov 2013to Feb 2017
Phase
Phase 1/2
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must sign and date informed consent prior to any study procedures.
  • Male and female patients aged 18-65 years.
  • Rheumatoid arthritis (RA) diagnosed from 6 months to 10 years ago in accordance with American College of Rheumatology (ACR) diagnostic criteria of rheumatoid arthritis, 1987, or ACR / European League against Rheumatism (EULAR), 2010.
  • Patients for whom standard treatment does not result in sufficient control of symptoms of RA, per investigator opinion.
  • Treatment with Methotrexate for at least 3 months before Screening visit, and a stable dose of ≥ 10 mg weekly for at least 28 days before the first infusion of the study drug. Patients should be also treated with folic acid.
  • Active disease of RA despite standard treatment:
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  • At least 6 out of 66 joints are swollen and at least 6 out of 68 joints are painful.
  • Level of C-reactive protein >= 15 mg/L or erythrocyte sedimentation rate >= 28 mm/hour or morning stiffness > 45 minutes.
  • Rheumatoid factor > 20 IU/mL.
  • Adequate hematological, renal and hepatic laboratory values.
  • For men and women of childbearing potential: consent to use double barrier methods of contraception during the entire study period.

Who cannot join

  • Use of other disease-modifying antirheumatic drugs (DMARDs) except for Methotrexate within 4 weeks before the treatment initiation. Use of Leflunomide within 8 weeks before the first study drug infusion. Use of biological immunosuppressive drugs (Adalimumab, Etanercept, Infliximab, Anakinra, Abatacept and others) 2 months before the first study drug administration. Use of Rituximab within 12 months before the first study drug administration.
  • Change of Methotrexate dose within 4 weeks before study treatment initiation.
  • Any autoimmune disease except for rheumatoid arthritis and dry keratoconjunctivitis.
  • Functional grade IV based on American College of Rheumatology scale.
  • Active rheumatoid vasculitis.
  • Any systemic diseases related to joint inflammation.
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  • Pregnant and breastfeeding women.
  • Women with childbearing potential refusing to use effective contraceptive methods during the entire study period.
  • Any active infectious disease or tuberculosis at the moment or within 2 weeks before inclusion into the study.
  • Syphilis, hepatitis В, С, HIV-infection or tuberculosis based on the results of laboratory tests at Screening visit.
  • Vaccination with live or attenuated vaccines within 6 weeks before the first study drug administration; planned vaccination during the study period.
  • Medical history of recurrent clinically significant infections.
  • Primary or secondary immunodeficiency.
  • Medical history of malignant oncologic diseases except for excised basal cell skin cancer.
  • Treatment with glucocorticosteroids (GKS) in a dose corresponding to over 12.5 mg/day of prednisolone equivalent, or change of GKS dose as well as treatment with intraarticular, i/m or i/v injections of GKS within 4 weeks before the first infusion of the study drug except for topical low active GKS, GKS in eardrops or eyedrops/ointment, inhalant GKS in a stable dose for the entire study period.
  • Dose change of non-steroid anti-inflammatory agents within 4 weeks before first infusion of the study drug.
  • Any factors that per investigator opinion might prevent patient from adhering to the visit schedule or performing study requirements.
  • Participation in any other clinical study of an experimental drug within 3 months or within 5 elimination half-lives (depending on whichever is longer) before the first infusion of the study drug.
  • Medical history of the following diseases: myocardial infarction, angina pectoris, bronchial asthma, chronic obstructive pulmonary disease or other cardiovascular or respiratory pathology which is considered serious by investigator.
  • Current uncontrolled pathology of renal, endocrine, hematology or central nervous system.
  • Alcohol and/or drug abuse within 1 year before first study drug administration.

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

  • State Scientific and Research Rheumatology Institute

    Moscow, 115522

  • Clinical Emergency Hospital of Yaroslavl

    Yaroslavl, 150003

Other trials in Russia

About this study

Official title: Safety, Tolerability, Pharmacodynamics and Efficacy Study of TAB08 in Patients With Rheumatoid Arthritis in Which Methotrexate (MTX) Treatment is Not Effective

This study is in two stages:

Stage 1 purpose is to assess safety, tolerability, and efficacy of multiple TAB08 doses in patients with active Rheumatoid Arthritis in which methotrexate (MTX) treatment is not enough effective.

Stage 2 purpose is to assess efficacy parameters (ACR criteria) of at least one selected TAB08 dose in extended patient population with active Rheumatoid Arthritis in which methotrexate (MTX) treatment with at least 10 mg/week is not enough effective.

Read the detailed description

Stage 1 is designed as standard phase 1 study with one arm and sequential dose cohorts with ascending doses. Each patient in each dose cohort will be administered TAB08 several times. After last TAB08 administration each patient will undergo investigational-treatment-free follow-up period.

At Stage 2 at least one TAB08 dose, selected during Stage 1 will be studied during longer timeframe in extended patient population.

Being tested
TAB08
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TAB08Drug

    Also called Theralizumab

    Weekly intravenous administration in escalating doses.

Study groups in NCT01990157
Study groupRoleWhat they receive
TAB08ExperimentalMultiple TAB08 administrations as intravenous infusions.
Receives: Drug: TAB08

What is being measured

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

  1. Incidence of dose-limiting toxicity in every dose cohort

    Measured: From study drug infusion (Day 1) untill week 2 (Day 15) for each patient

Secondary outcomes (1)

  1. Number of adverse events

    Measured: From study drug infusion (Day 1) untill the end of study stage 1 (Day 85)

Timeline

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

  1. First posted21 Nov 2013 (estimated)
  2. Study startNov 2013
  3. Primary completionDec 2015
  4. Study completionFeb 2017

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01990157
Sponsor's protocol ID
TAB08_RA01
Status last verified
Feb 2017
First submitted
5 Nov 2013
Last updated
28 Feb 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TAB08 in people with Rheumatoid Arthritis, run by Theramab LLC at 2 sites in Russia.

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 11 inclusion and 21 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 28 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

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 of dose-limiting toxicity in every dose cohort (time frame: From study drug infusion (Day 1) untill week 2 (Day 15) for each patient). 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 NCT01990157.

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 28 Feb 2017.

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